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ATOMOXETINE capsule


  1. Suicidal Thoughts And Actions In Children And Teenagers:
  2. The Chance For Suicidal Thoughts And Actions May Be Higher:
  3. Prevent Suicidal Thoughts And Action In Your Child Or Teenager By:
  4. Atomoxetine Capsules Treatment:
  5. 3.heart-related Problems:
  6. 4.new Mental (psychiatric) Problems In Children And Teenagers:
  7. Who Should Not Take Atomoxetine Capsules? Atomoxetine Capsules Should Not Be Taken If You Or Your Child:
  8. Atomoxetine Capsules Be Taken?
  9. Distributed By:
  10. What Are Atomoxetine Capsules?
  11. How Should Atomoxetine Capsules Be Taken?
  12. Active Ingredient:
  13. Inactive Ingredients:
  14. Manufactured By:
  15. Patient Information
  16. 1. Suicidal Thoughts And Actions In Children And Teenagers:
  17. 3. Heart-related Problems:
  18. 4. New Mental (psychiatric) Problems In Children And Teenagers:
  19. What Is Atomoxetine Hydrochloride?
  20. Especially Tell Your Doctor If You Or Your Child Takes:
  21. How Shlould Atomoxetine Capsules Be Taken?
  22. What Are Possible Side Effects Of Atomoxetine Capsules?
  23. Watch For The Following Signs In Your Child Or Teenager During Atomoxetine Capsules Treatment:
  24. Atomoxetine Capsules Can Cause Liver Injury In Some Patients. Call Your Doctor Right Away If You Or Your Child Has The Following Signs Of Liver Problems:
  25. Atomoxetine Capsules Should Not Be Taken If You Or Your Child:
  26. Other Serious Side Effects Include:
  27. Manufactured For:
  28. Revised: 7/2019document Id:
  29. Heart-related Problems:
  30. New Mental (psychiatric) Problems In Children And Teenagers:
  31. What Are Atomoxetine Capsules?
  32. Atomoxetine Capsules Can Cause Liver Injury In Some Patients. Call Your Doctor Right Away If You Or Your Child Has The Following Signs Of Liver Problems:
  33. Distributed By:

Suicidal Thoughts And Actions In Children And Teenagers: 

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results fromatomoxetine capsules clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions.Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager (or there is a family history of):

has bipolar illness (manic-depressive illness)

  • had suicide thoughts or actions before starting atomoxetine capsules

The Chance For Suicidal Thoughts And Actions May Be Higher: 

early during atomoxetine capsules treatment

  • during dose adjustments

Prevent Suicidal Thoughts And Action In Your Child Or Teenager By: 

  • paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during atomoxetine capsules treatment
  • keeping all follow-up visits with your child or teenager's doctor as scheduled

Watch for the following signs in your child or teenager during

Atomoxetine Capsules Treatment: 

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts

Call your child or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe.Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

3.heart-related Problems: 

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine capsules.

Your doctor should check your blood pressure or your child's blood pressure and heart rate regularly during treatment with atomoxetine capsules.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while takingatomoxetine capsules.

4.new Mental (psychiatric) Problems In Children And Teenagers: 

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager's doctor right away about any new mental symptomsbecause adjusting or stopping atomoxetine capsules treatment may need to be considered.

What are atomoxetine Capsules?

Atomoxetine capsules are a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Atomoxetine capsules have not been studied in children less than 6 years old.

Who Should Not Take Atomoxetine Capsules? Atomoxetine Capsules Should Not Be Taken If You Or Your Child: 

  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil(phenelzine sulfate), Parnate(tranylcypromine sulfate) and Emsam(selegiline transdermal system).
  • have an eye problem called narrow angle glaucoma
  • are allergic to anything in atomoxetine capsules.

    Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.Atomoxetine capsules and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine capsules can be taken with other medicines.

Atomoxetine Capsules Be Taken? 

  • Takeatomoxetinecapsulesexactly as prescribed.Atomoxetinecomes in different dose strength capsules.Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules.Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
  • Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes or your child's eyes, rinse them with water right away and call your doctor.
  • Atomoxetine capsules can be taken with or without food.
  • Atomoxetine capsule is usually taken once or twice a day. Take atomoxetine capsules at the same time each day to help you remember. If you miss a dose of atomoxetine capsules, take it as soon as you remember that day. If you miss a day of atomoxetine capsules, do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop atomoxetine capsules treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine capsules. Children should have their height and weight checked often while taking atomoxetine capsules. Atomoxetine capsules treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too muchatomoxetine capsules or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects ofatomoxetine capsules?

  • Store atomoxetine capsules in a safe place at 20 to 25 C (68 to 77 F)
  • Keep atomoxetine capsules and all medicines out of the reach of children.

General information about atomoxetinecapsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which it was not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

What are the ingredients in

Distributed By: 

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 07/17

What Are Atomoxetine Capsules? 

Atomoxetine capsules are selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Atomoxetine capsules have not been studied in children less than 6 years old.

How Should Atomoxetine Capsules Be Taken? 

Take atomoxetine capsules exactly as prescribed. Atomoxetine capsules come in different dose strength capsules.Your doctor may adjust the dose until it is right for you or your child.
Do not chew, crush, or open the capsules.Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes or your child's eyes, rinse them with water right away and call your doctor.
Atomoxetine capsule can be taken with or without food.
Atomoxetine capsule is usually taken once or twice a day. Take atomoxetine capsule at the same time each day to help you remember. If you miss a dose of atomoxetine capsules, take it as soon as you remember that day. If you miss a day of atomoxetine capsules, do not double your dose the next day. Just skip the day you missed.
From time to time, your doctor may stop atomoxetine capsules treatment for a while to check ADHD symptoms.
Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine capsules. Children should have their height and weight checked often while taking atomoxetine capsules. Atomoxetine capsules treatment may be stopped if a problem is found during these check-ups.
If you or your child takes too much atomoxetine capsules or overdoses, call your doctor or poison control center right away, or get emergency treatment.

Active Ingredient: 

atomoxetine hydrochloride USP.

Inactive Ingredients: 

pregelatinized starch, gelatin, and titanium dioxide. The capsule shell for atomoxetine capsules USP, 18 mg contains D&C Yellow No. 10, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide.
The capsule shell for atomoxetine capsules USP, 25 mg and 40 mg contains D&C Red No. 28, FD&C Blue No.1, gelatin, and titanium dioxide.
The capsule shell for atomoxetine capsules USP, 60 mg contains D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, sodium lauryl sulfate, and titanium dioxide.
The capsule shell for atomoxetine capsules USP, 80 mg and 100 mg contains D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, gelatin, and titanium dioxide.
The imprinting ink for atomoxetine capsules USP, 10 mg, 25 mg, 40 mg, 80 mg, and 100 mg has the following components: black iron oxide, butyl alcohol, D&C Yellow No. 10, ethanol, FD&C Blue No. 2, FD&C Blue No. 1, FD&C Red No. 40, methanol, propylene glycol, and shellac.
The imprinting ink for atomoxetine capsules USP, 18 mg and 60 mg has the following components: black iron oxide, butyl alcohol, ethanol, isopropyl alcohol, propylene glycol, potassium hydroxide, strong ammonia solution, and shellac.

Nardilis a registered trademark of Pfizer Inc.

Parnateis a registered trademark of GlaxoSmithKline.

Emsamis a registered trademark of Somerset Pharmaceuticals Inc.

This Medication Guide has been approved by the US Food and Drug Administration.
Medication Guide available at www.northstarrxllc.com/products or call 1800-206-7821

Manufactured By: 

Glenmark Pharmaceuticals Ltd
Colvale-Bardez, Goa 403513, India
July 2019

10mg

18mg

Patient Information 

ATOMOXETINE CAPSULES, USP

(A-toe-MOX-e-teen)

Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child s treatment with atomoxetine hydrochloride.

1. Suicidal Thoughts And Actions In Children And Teenagers: 

Children and teenagers sometimes think about suicide, and many report trying to kill themselves. Results from atomoxetine hydrochloride clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions.Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager s doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)

  • had suicide thoughts or actions before starting atomoxetine capsules.

3. Heart-related Problems: 

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine capsules.Your doctor should check your blood pressure or your child s blood pressure and heart rate regularly during treatment with atomoxetine capsules.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine capsules.

4. New Mental (psychiatric) Problems In Children And Teenagers: 

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager s doctor right away about any new mental symptomsbecause adjusting or stopping atomoxetine hydrochloride treatment may need to be considered.

What Is Atomoxetine Hydrochloride? 

Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine hydrochloride may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Atomoxetine capsules has not been studied in children less than 6 years old.

Especially Tell Your Doctor If You Or Your Child Takes: 

  • asthma medicines
  • anti-depression medicines including MAOIs
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking atomoxetine capsules without talking to your doctor first.

How Shlould Atomoxetine Capsules Be Taken? 

  • Take atomoxetinecapsules exactly as prescribed. Atomoxetine hydrochloride comes in different dose strength capsules.Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules.Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
  • Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes or your child s eyes, rinse them with water right away and call your doctor.
  • Atomoxetine capsules can be taken with or without food.
  • Atomoxetine capsules are usually taken once or twice a day. Take atomoxetine capsules at the same time each day to help you remember. If you miss a dose of atomoxetine capsules, take it as soon as you remember that day. If you miss a day of atomoxetine capsules, do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop atomoxetine hydrochloride treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine capsules. Children should have their height and weight checked often while taking atomoxetine capsules. Atomoxetine hydrochloride treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much atomoxetine capsules or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What Are Possible Side Effects Of Atomoxetine Capsules? 

  • Store atomoxetine capsules in a safe place at room temperature, 20 25 C (68 77 F).
  • Keep atomoxetine capsules and all medicines out of the reach of children.

General information about atomoxetinecapsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which it was not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. It may harm them. This Medication Guide summarizes the most important information about atomoxetine hydrochloride. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine hydrochloride that was written for healthcare professionals. For more information about atomoxetine hydrochloride call 1-888-375-3784.

Watch For The Following Signs In Your Child Or Teenager During Atomoxetine Capsules Treatment: 

7.
anxiety
8.
agitation
9.
panic attacks
10.
trouble sleeping
11.
irritability
12.
hostility
13.
aggressiveness
14.
impulsivity
15.
restlessness
16.
mania
17.
depression
18.
suicide thoughts
Call your child or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe.Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

Atomoxetine Capsules Can Cause Liver Injury In Some Patients. Call Your Doctor Right Away If You Or Your Child Has The Following Signs Of Liver Problems: 

1.
itching
2.
right upper belly pain
3.
dark urine
4.
yellow skin or eyes
5.
unexplained flu-like symptoms

Atomoxetine Capsules Should Not Be Taken If You Or Your Child: 

1.
are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil(phenelzine sulfate), Parnate(tranylcypromine sulfate) and Emsam(selegiline transdermal system).
2.
have an eye problem called narrow angle glaucoma
3.
are allergic to anything in atomoxetine capsules.

Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.Atomoxetine capsules and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine capsules can be taken with other medicines.

Other Serious Side Effects Include: 

1.
serious allergic reactions (call your doctor if you have trouble breathing,

Store atomoxetine capsules in a safe place at room temperature, 59 to 86 F (15 to 30 C).
Keep atomoxetine capsules and all medicines out of the reach of children.

General information about atomoxetine capsules

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which it was not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. For more information about atomoxetine capsules, call Glenmark Pharmaceuticals Inc., USA at 1(888)721-7115.

Manufactured For: 

Z:\Regulatory Affairs 2\ANDAs\Atomoxetine (79019)\_Misc\0005\Pratik Labeling\logo.jpg

Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ 07430

Questions? 1 (888)721-7115

www.glenmarkpharma.com/usa

July 2019

PACKAGE LABEL - Atomoxetine capsules 10 mg bottle of 30

30 Capsules

NDC 68462-265-30

Rx only

10 mg

Each capsule equivalent to 10 mg atomoxetine

Do not use if inner seal is missing or broken.

10mg-30-count

PACKAGE LABEL - Atomoxetine capsules 18 mg bottle of 30

30 Capsules

NDC 68462-266-30

Rx only

18 mg

Each capsule equivalent to 18 mg atomoxetine

Do not use if inner seal is missing or broken.

18mg-30-count

PACKAGE LABEL - Atomoxetine capsules 25 mg bottle of 30

30 Capsules

NDC 68462-267-30

Rx only

25 mg

Each capsule equivalent to 25 mg atomoxetine

Do not use if inner seal is missing or broken.

25mg-30-count

PACKAGE LABEL - Atomoxetine capsules 40 mg bottle of 30

30 Capsules

NDC 68462-268-30

Rx only

40 mg

Each capsule equivalent to 40 mg atomoxetine

Do not use if inner seal is missing or broken.

40mg-30-count

PACKAGE LABEL - Atomoxetine capsules 60 mg bottle of 30

30 Capsules

NDC 68462-269-30

Rx only

60 mg

Each capsule equivalent to 60 mg atomoxetine

Do not use if inner seal is missing or broken.

60mg-30-count

PACKAGE LABEL - Atomoxetine capsules 80 mg bottle of 30

30 Capsules

NDC 68462-270-30

Rx only

80 mg

Each capsule equivalent to 80 mg atomoxetine

Do not use if inner seal is missing or broken.

80mg-30-count

PACKAGE LABEL - Atomoxetine capsules 100 mg bottle of 30

30 Capsules

NDC 68462-271-30

Rx only

100 mg

Each capsule equivalent to 100 mg atomoxetine

Do not use if inner seal is missing or broken.

100mg-30-count.jpg
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-265
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorWHITE (Opaque White) , WHITE (Opaque White)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code265;10
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-265-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-265-232000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-266
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE18 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorYELLOW (Opaque Yellow) , WHITE (Opaque White)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code266;18
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-266-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-266-232000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-267
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorBLUE (Opaque Blue) , WHITE (Opaque White)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code267;25
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-267-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-267-232000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-268
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE40 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorBLUE (Opaque Blue) , BLUE (Opaque Blue)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code268;40
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-268-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-268-232000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-269
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE60 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
AMMONIA(UNII: 5138Q19F1X)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorBLUE (Opaque Blue) , YELLOW (Opaque Yellow)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code269;60
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-269-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-269-232000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-270
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE80 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 28(UNII: 767IP0Y5NH)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorBROWN (Opaque Reddish Brown) , WHITE (Opaque White)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code270;80
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-270-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-270-232000 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
ATOMOXETINE
atomoxetine capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68462-271
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATOMOXETINE HYDROCHLORIDE(UNII: 57WVB6I2W0) (ATOMOXETINE - UNII:ASW034S0B8)ATOMOXETINE100 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 28(UNII: 767IP0Y5NH)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
ALCOHOL(UNII: 3K9958V90M)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
METHYL ALCOHOL(UNII: Y4S76JWI15)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
Product Characteristics
ColorBROWN (Opaque Reddish Brown) , BROWN (Opaque Reddish Brown)Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code271;100
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-271-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
2NDC:68462-271-511500 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07901905/30/2017
Labeler -Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
NameAddressID/FEIBusiness Operations
Glenmark Pharmaceuticals Limited677318665MANUFACTURE(68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271) , ANALYSIS(68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271)
Establishment
NameAddressID/FEIBusiness Operations
Hetero Labs Limited650435873API MANUFACTURE(68462-265, 68462-266, 68462-267, 68462-268, 68462-269, 68462-270, 68462-271)

Revised: 7/2019document Id: 

9a26fd06-5ed0-4fbf-9bd7-2bf81ed86e79Set id: 0ab8d905-e890-4e91-a730-3e5d12f5c23fVersion: 2Effective Time: 20190710Glenmark Pharmaceuticals Inc., USA

Heart-related Problems: 

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate
  • Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine capsules.

    Your doctor should check your blood pressure or your child s blood pressure and heart rate regularly during treatment with atomoxetine capsules.

    Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine capsules.

    New Mental (psychiatric) Problems In Children And Teenagers: 

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms
  • Call your child or teenager s doctor right away about any new mental symptomsbecause adjusting or stopping atomoxetine capsules treatment may need to be considered.

    What Are Atomoxetine Capsules? 

    Atomoxetine capsules are selective norepinephrine reuptake inhibitor medicine. They are used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

    Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

    Atomoxetine capsules have not been studied in children less than 6 years old.

    Atomoxetine Capsules Can Cause Liver Injury In Some Patients. Call Your Doctor Right Away If You Or Your Child Has The Following Signs Of Liver Problems: 

    1.
    itching
    2.
    right upper belly pain
    3.
    dark urine
    4.
    yellow skin or eyes
    5.
    unexplained flu-like symptoms

    Distributed By: 

    MAJOR PHARMACEUTICALS

    17177 N Laurel Park Dr., Suite 233

    Livonia, MI 48152

    Refer to package label for Distributor's NDC Number

    Issued: 0517



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