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DRONABINOL capsule


  1. Can Cause Serious Side Effects, Including:
  2. A Prescription Medicine Used In Adults To Treat:
  3. Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  4. May Cause Serious Side Effects, Including:
  5. The Most Common Side Effects Of Dronabinol Capsules Include:
  6. Active Ingredient:
  7. Ingredients:
  8. Manufactured For:
  9. Manufactured By:
  10. Patient Information
  11. How Should I Take Dronabinol Capsules?
  12. What Are The Possible Side Effects Of Dronabinol Capsules? Dronabinol Capsules May Cause Serious Side Effects, Including:
  13. [dronabinol Capsules Are A Prescription Medicine Used In Adults To Treat:
  14. Do Not Take Dronabinol Capsules If You:
  15. Before Taking Dronabinol Capsules, Tell Your Doctor About All Of Your Medical Conditions, Including If You:
  16. How Should I Take Dronabinol Capsules?
  17. Dronabinol Capsules May Cause Serious Side Effects, Including:
  18. How Should I Store Dronabinol Capsules?
  19. Distributed By:
  20. Revised: 12/2018document Id:
  21. Dronabinol Capsules Can Cause Serious Side Effects, Including:
  22. Dronabinol Capsules Are A Prescription Medicine Used In Adults To Treat:
  23. What Are The Ingredients In Dronabinol Capsules?
  24. Inactive Ingredients:
  25. Principal Display Panel Text For Container Label:
  26. Principal Display Panel Text For Carton Label:
  27. Revised: 11/2017document Id:

Can Cause Serious Side Effects, Including: 

  • Worseningmental(psychiatric)symptoms.Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take dronabinol capsules. Dronabinol capsules taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take dronabinol capsules may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.

  • Problemsthinkingclearly.Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.

  • Changes in your blood pressure.Dronabinol capsules may increase or decrease your blood pressure, especially when you start taking dronabinol capsules or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.
What aredronabinol capsules?
  • Dronabinol capsulesare

A Prescription Medicine Used In Adults To Treat: 

  • loss of appetite (anorexia) in people with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.

  • nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.

Dronabinol capsules are a controlled substance (CIII) because it contains dronabinol, which can be a target for people who abuse prescription medicines or street drugs. Keep your dronabinol capsules in a safe place to protect it from theft. Never give your dronabinol capsules to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.

It is not known if dronabinol capsules are safe and effective in children.Do not take dronabinol capsulesifyou:
  • had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.

  • had an allergic reaction to sesame oil.
Beforetakingdronabinol capsules,

Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have or had heart problems.

  • have or had problems with drug abuse or dependence.

  • have or had problems with alcohol abuse or dependence.

  • have or had mental health problems including mania, depression, or schizophrenia.

  • have had a seizure or have a medical condition that may increase your risk of having a seizure.

  • are pregnant or plan to become pregnant. Dronabinol capsules may harm your unborn baby. Avoid the use of dronabinol capsules if you are pregnant.

  • are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their breast milk to the baby. It is not known if dronabinol capsules pass into your breast milk. Talk to your doctor about the best way to feed your baby if you take dronabinol capsules. Do not breastfeed while taking dronabinol capsules and for 9 days after your last dose of dronabinol capsules if you are being treated for nausea and vomiting caused by anti-cancer medicine.

Tell your doctor about all the medicines you take or have taken in the last 14 days,including prescription and over the-counter medicines, vitamins, and herbal supplements. Dronabinol capsules and certain other medicines can affect each other, causing serious side effects.

How should I takedronabinol capsules?

  • Take dronabinol capsules exactly as your doctor tells you to. Your doctor may change your dose after

    • Do not drive, operate machinery, or do other dangerous activities until you know how dronabinol capsules affect you. Dronabinol capsules taken with other medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.

    What are the possible side effects ofdronabinol capsules?Dronabinol capsules

May Cause Serious Side Effects, Including: 

  • Seizures.Dronabinol capsules may increase your risk of seizures. Stop taking dronabinol capsules and call your doctor and get medical care right away if you have a seizure during treatment with dronabinol capsules.

  • Drugandalcohol abuse.You may have an increased risk of abusing dronabinol capsules if you have a history of drug or alcohol abuse or dependence, including marijuana. Tell your doctor if you develop abuse behaviors such as increased irritability, nervousness, restlessness or want more or higher doses of dronabinol capsules during your treatment.

  • Nausea,vomiting, or stomach-area (abdominal) pain.Tell your doctor if you have nausea, vomiting, or abdominal pain or if your nausea, vomiting, or abdominal pain gets worse during treatment with dronabinol capsules.

The Most Common Side Effects Of Dronabinol Capsules Include: 

  • dizziness
  • feeling extremely happy (euphoria)
  • overly suspicious or feeling people want to harm you (paranoid reaction)
  • sleepiness
  • abnormal thoughts
  • stomach-area (abdominal) pain
  • nausea
  • vomiting

These are not all the possible side effects of dronabinol capsules. Tell your doctor if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.

How should I storedronabinol capsules?

  • Store dronabinol capsules in a cool place such as in a refrigerator, at a temperature between 36 F to 46 F (2 C to 8 C).

  • Do notfreeze dronabinol capsules.

  • Keep the dronabinol capsules container closed tightly.

Keep dronabinol capsules and all medicines out of the reach of children.

Generalinformationabout the safe and effective use ofdronabinol capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use dronabinol capsules for a condition for which it was not prescribed. Do not give dronabinol capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about dronabinol capsules that is written for health professionals.

What are the ingredients indronabinol capsules?

Active Ingredient: 

dronabinol

Inactive

Ingredients: 

Capsules for oral administration are supplied as oval, soft gelatin capsules containing either 2.5 mg, 5 mg, or 10 mg dronabinol. Each capsule strength is formulated with the following inactive ingredients: 2.5 mg capsules contain gelatin, glycerin, sesame oil, titanium dioxide, and FD&C Red No. 40; 5 mg capsules contain gelatin, glycerin, sesame oil, titanium dioxide, FD&C Yellow No. 6, FD&C Red No. 40 and FD&C Blue No. 1; and 10 mg capsules contain gelatin, glycerin, sesame oil, titanium dioxide and FD&C Yellow No. 6.

Manufactured For: 

Lannett Company, Inc.

Philadelphia, PA 19154

Manufactured By: 

SWISS CAPS AG

Husenstrasse 35

9533 Kirchberg

Switzerland

For more information call 1-844-834-0530.

This Patient Information has been approved by the U.S. Food and Drug Administration.


CIB71920A

Rev. 04/2018

Patient Information 

*
Ingredients in imprint ink

8437501/0618

DRONABINOL (droe nab' i nol) CAPSULES, USP

for oral use, CIII

How Should I Take Dronabinol Capsules? 

  • Take dronabinol capsules exactly as your doctor tells you to. Your doctor may change your dose after

    • Do not drive, operate machinery, or do other dangerous activities until you know how dronabinol capsules affects you. Dronabinol capsules taken with other medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.

What Are The Possible Side Effects Of Dronabinol Capsules? Dronabinol Capsules May Cause Serious Side Effects, Including: 

  • "
  • Seizures.Dronabinol capsules may increase your risk of seizures. Stop taking dronabinol capsules and call your doctor and get medical care right away if you have a seizure during treatment with dronabinol capsules.
  • Drug and alcohol abuse.You may have an increased risk of abusing dronabinol capsules if you have a history of drug or alcohol abuse or dependence, including marijuana. Tell your doctor if you develop abuse behaviors such as increased irritability, nervousness, restlessness or want more or higher doses of dronabinol capsules during your treatment.
  • Nausea, vomiting, or stomach-area (abdominal) pain.Tell your doctor if you have nausea, vomiting, or abdominal pain or if your nausea, vomiting, or abdominal pain gets worse during treatment with dronabinol capsules.

[dronabinol Capsules Are A Prescription Medicine Used In Adults To Treat: 

  • loss of appetite (anorexia) in people with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
  • nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.
Dronabinol capsules is a controlled substance (CIII) because it contains dronabinol, which can be a target for people who abuse prescription medicines or street drugs. Keep your dronabinol capsules in a safe place to protect it from theft. Never give your dronabinol capsules to anyone else because it may cause death or harm them. Selling or giving away this medicine is against the law.
It is not known if dronabinol capsules are safe and effective in children.

Do Not Take Dronabinol Capsules If You: 

  • had an allergic reaction to dronabinol. Signs and symptoms of an allergic reaction to dronabinol include: swelling of the lips, hives, a rash over your whole body, mouth sores, skin burning, flushing, and throat tightness.
  • had an allergic reaction to sesame oil.

Before Taking Dronabinol Capsules, Tell Your Doctor About All Of Your Medical Conditions, Including If You: 

  • have or had heart problems.
  • have or had problems with drug abuse or dependence.
  • have or had problems with alcohol abuse or dependence.
  • have or had mental health problems including mania, depression, or schizophrenia.
  • have had a seizure or have a medical condition that may increase your risk of having a seizure.
  • are pregnant or plan to become pregnant. Dronabinol capsules may harm your unborn baby. Avoid the use of dronabinol capsules if you are pregnant.
  • are breastfeeding or plan to breastfeed. The Centers for Disease Control and Prevention recommends that mothers with HIV not breastfeed because they can pass the HIV through their breast milk to the baby. It is not known if dronabinol capsules passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take dronabinol capsules. Do not breastfeed while taking dronabinol capsules and for 9 days after your last dose of dronabinol capsules if you are being treated for nausea and vomiting caused by anti-cancer medicine.
Tell your doctor about all the medicines you take or have taken in the last 14 days,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Dronabinol capsules and certain other medicines can affect each other, causing serious side effects.

How Should I Take Dronabinol Capsules? 

  • Take dronabinol capsules exactly as your doctor tells you to. Your doctor may change your dose after
    • Do not drive, operate machinery, or do other dangerous activities until you know how dronabinol capsules affects you. Dronabinol capsules taken with other medicines that cause dizziness, confusion, and sleepiness may make these symptoms worse.

Dronabinol Capsules May Cause Serious Side Effects, Including: 

  • Seizures.Dronabinol capsules may increase your risk of seizures. Stop taking dronabinol capsules and call your doctor and get medical care right away if you have a seizure during treatment with dronabinol capsules.
  • Drug and alcohol abuse.You may have an increased risk of abusing dronabinol capsules if you have a history of drug or alcohol abuse or dependence, including marijuana. Tell your doctor if you develop abuse behaviors such as increased irritability, nervousness, restlessness or want more or higher doses of dronabinol capsules during your treatment.
  • Nausea, vomiting, or stomach-area (abdominal) pain.Tell your doctor if you have nausea, vomiting, or abdominal pain or if your nausea, vomiting, or abdominal pain gets worse during treatment with dronabinol capsules.
The most common side effects of dronabinol capsules include:
  • dizziness
  • feeling extremely happy (euphoria)
  • overly suspicious or feeling people
    want to harm you (paranoid reaction)
  • sleepiness
  • abnormal thoughts
  • stomach-area (abdominal) pain
  • nausea
  • vomiting
These are not all the possible side effects of dronabinol capsules. Tell your doctor if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Dronabinol Capsules? 


  • Store dronabinol capsules in a cool place such as in a refrigerator, at a temperature between 46 F to 59 F (8 C to 15 C).
  • Do notfreeze dronabinol capsules.
  • Keep the dronabinol capsules container closed tightly.
Keep dronabinol capsules and all medicines out of the reach of children.General information about the safe and effective use of dronabinol capsules
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use dronabinol capsules for a condition for which it was not prescribed. Do not give dronabinol capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about dronabinol capsules that is written for health professionals.

Distributed By: 

Ascend Laboratories, LLC, Parsippany, NJ 07054
For more information, call 1-877-ASC-RX01 (1-877-272-7901).

This Patient Information has been approved by the U.S. Food and Revised: December, 2017
Drug Administration.

1248C99 08/17


NDC 67877-568-60

ASCEND Laboratories, LLC

CIII

Dronabinol Capsules, USP

2.5 mg

PRESCRIPTION PREPACK

UNIT-OF-USE

Rx Only

60 Capsules

carton-dronabinol-2-5mg-60ct-ascend

NDC 67877-569-60

ASCEND Laboratories, LLC

CIII

Dronabinol Capsules, USP

5 mg

Rx Only

60 Capsules

carton-dronabinol-5mg-60ct-ascend

NDC 67877-570-60

ASCEND Laboratories, LLC

CIII

Dronabinol Capsules, USP

10 mg

Rx Only

60 Capsules

carton-dronabinol-10mg-60ct-ascend
DRONABINOL
dronabinol capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67877-568
Route of AdministrationORALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dronabinol(UNII: 7J8897W37S) (dronabinol - UNII:7J8897W37S)dronabinol2.5 mg
Inactive Ingredients
Ingredient NameStrength
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITE (white)Scoreno score
ShapeROUND (ROUND)Size8mm
FlavorImprint CodeUM
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67877-568-601 in 1 CARTON05/10/2017
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865105/10/2017
DRONABINOL
dronabinol capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67877-569
Route of AdministrationORALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dronabinol(UNII: 7J8897W37S) (dronabinol - UNII:7J8897W37S)dronabinol5 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED(UNII: 1K09F3G675)
ferrosoferric oxide(UNII: XM0M87F357)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
titanium dioxide(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
Product Characteristics
ColorBROWN (brown)Scoreno score
ShapeROUND (ROUND)Size8mm
FlavorImprint CodeUM
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67877-569-601 in 1 CARTON05/10/2017
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865105/10/2017
DRONABINOL
dronabinol capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:67877-570
Route of AdministrationORALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dronabinol(UNII: 7J8897W37S) (dronabinol - UNII:7J8897W37S)dronabinol10 mg
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED(UNII: 1K09F3G675)
ferric oxide yellow(UNII: EX438O2MRT)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
titanium dioxide(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
Product Characteristics
ColorORANGE (orange)Scoreno score
ShapeROUND (ROUND)Size8mm
FlavorImprint CodeUM
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67877-570-601 in 1 CARTON05/10/2017
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01865105/10/2017
Labeler -Ascend Laboratories, LLC (141250469)

Revised: 12/2018document Id: 

bf1e78ab-ef4f-4e8a-214b-6a97d78c629bSet id: 0bb05433-4ffb-4b0e-42f4-7549b3646bc1Version: 19Effective Time: 20181203Ascend Laboratories, LLC

Dronabinol Capsules Can Cause Serious Side Effects, Including: 

  • Worsening mental (psychiatric) symptoms. Psychiatric symptoms can worsen in people who have mania, depression, or schizophrenia and who take dronabinol capsules. Dronabinol capsules taken with medicines that cause psychiatric symptoms can worsen psychiatric symptoms. Elderly people who take dronabinol capsules may have a greater risk of having psychiatric symptoms. Tell your doctor if you have new or worsening mood symptoms, including symptoms of mania, depression, or schizophrenia.
  • Problems thinking clearly.Tell your doctor if you have trouble remembering things, concentrating, have increased sleepiness, or confusion. Elderly people may have a greater risk of having problems thinking clearly.
  • Changes in your blood pressure.Dronabinol capsules may increase or decrease your blood pressure, especially when you start taking dronabinol capsules or when your dose is changed. Tell your doctor if you have signs or symptoms of changes in your blood pressure including: headaches, vision problems, dizziness, feeling lightheaded, fainting, or a fast heartbeat. Elderly people, especially those with dementia, and people with heart problems may have an increased risk of changes in blood pressure and an increased risk of falls.

Dronabinol Capsules Are A Prescription Medicine Used In Adults To Treat: 

  • loss of appetite (anorexia) in people with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
  • nausea and vomiting caused by anti-cancer medicine (chemotherapy) in people whose nausea and vomiting have not improved with usual anti-nausea medicines.

Dronabinol capsules are a controlled substance (CIII) because it contains dronabinol, which can be a target for people who abuse prescription medicines or street drugs. Keep your dronabinol capsules in a safe place to protect them from theft. Never give your dronabinol capsules to anyone else because the capsules may cause death or harm them. Selling or giving away this medicine is against the law.

It is not known if dronabinol capsules are safe and effective in children.

What Are The Ingredients In Dronabinol Capsules? 

Active ingredient: dronabinol

Inactive Ingredients: 

2.5 mg capsules contain gelatin, glycerin, sesame oil, FD&C red No. 40, D&C yellow No. 10, titanium dioxide, iron oxide black, shellac glaze, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and purified water; 5 mg capsules contain gelatin, glycerin, sesame oil, FD&C yellow No. 6, FD&C red No. 40, FD&C blue No. 1, titanium dioxide, shellac glaze, simethicone, isopropyl alcohol, ammonium hydroxide, n-butyl alcohol, propylene glycol and purified water; 10 mg capsules contain gelatin, glycerin, sesame oil, FD&C yellow No. 6, titanium dioxide, iron oxide black, shellac glaze, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide and purified water.

This Patient Information has been approved by the U.S. Food and Drug Administration.

AKORN
Manufactured by USGP,
a division of PROCAPS forAkorn, Inc.,
Lake Forest, IL 60045

Made in Colombia.

DRA0N
Rev. 10/17

Principal Display Panel Text For Container Label: 

NDC 17478-761-06 60 Capsules

Dronabinol

Capsules USP

2.5 mg CIII

Do not use if seal around the cap imprinted

with SEALED for YOUR PROTECTION is

broken or missing.

Rx only Akorn Logo

Principal Display Panel Text for Container Label

Principal Display Panel Text For Carton Label: 

NDC 17478-763-06

Dronabinol

Capsules USP

10 mg CIII

Do not use if seal around the cap imprinted

with SEALED for YOUR PROTECTION is

broken or missing.

60 Capsules

Rx only Akorn Logo

Principal Display Panel Text for Carton Label
DRONABINOL
dronabinol capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-761
Route of AdministrationORALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dronabinol(UNII: 7J8897W37S) (Dronabinol - UNII:7J8897W37S)Dronabinol2.5 mg
Inactive Ingredients
Ingredient NameStrength
gelatin(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
FD&C red no. 40(UNII: WZB9127XOA)
D&C yellow no. 10(UNII: 35SW5USQ3G)
titanium dioxide(UNII: 15FIX9V2JP)
ferrosoferric oxide(UNII: XM0M87F357)
shellac(UNII: 46N107B71O)
isopropyl alcohol(UNII: ND2M416302)
butyl alcohol(UNII: 8PJ61P6TS3)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
water(UNII: 059QF0KO0R)
Product Characteristics
Colorbrown (beige)Scoreno score
ShapeROUND (ROUND)Size3mm
FlavorImprint Code61
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-761-061 in 1 CARTON06/20/2014
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921706/20/2014
DRONABINOL
dronabinol capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-762
Route of AdministrationORALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dronabinol(UNII: 7J8897W37S) (Dronabinol - UNII:7J8897W37S)Dronabinol5 mg
Inactive Ingredients
Ingredient NameStrength
gelatin(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
FD&C yellow no. 6(UNII: H77VEI93A8)
FD&C red no. 40(UNII: WZB9127XOA)
FD&C blue no. 1(UNII: H3R47K3TBD)
titanium dioxide(UNII: 15FIX9V2JP)
shellac(UNII: 46N107B71O)
dimethicone(UNII: 92RU3N3Y1O)
silicon dioxide(UNII: ETJ7Z6XBU4)
isopropyl alcohol(UNII: ND2M416302)
ammonia(UNII: 5138Q19F1X)
butyl alcohol(UNII: 8PJ61P6TS3)
propylene glycol(UNII: 6DC9Q167V3)
water(UNII: 059QF0KO0R)
Product Characteristics
Colorbrown (brown)Scoreno score
ShapeROUND (ROUND)Size3mm
FlavorImprint Code62
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-762-061 in 1 CARTON06/20/2014
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921706/20/2014
DRONABINOL
dronabinol capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-763
Route of AdministrationORALDEA ScheduleCIII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dronabinol(UNII: 7J8897W37S) (Dronabinol - UNII:7J8897W37S)Dronabinol10 mg
Inactive Ingredients
Ingredient NameStrength
gelatin(UNII: 2G86QN327L)
glycerin(UNII: PDC6A3C0OX)
sesame oil(UNII: QX10HYY4QV)
FD&C yellow no. 6(UNII: H77VEI93A8)
titanium dioxide(UNII: 15FIX9V2JP)
ferrosoferric oxide(UNII: XM0M87F357)
shellac(UNII: 46N107B71O)
isopropyl alcohol(UNII: ND2M416302)
butyl alcohol(UNII: 8PJ61P6TS3)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
water(UNII: 059QF0KO0R)
Product Characteristics
Colororange (orange)Scoreno score
ShapeROUND (ROUND)Size3mm
FlavorImprint Code63
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-763-061 in 1 CARTON06/20/2014
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07921706/20/2014
Labeler -Akorn, Inc. (062649876)

Revised: 11/2017document Id: 

8c067dc9-5bfd-4c27-bc5d-253f67d59635Set id: a0409d82-a61e-4b9e-8717-ced299ccedb2Version: 3Effective Time: 20171128Akorn, Inc.



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