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ADHANSIA XR- methylphenidate hydrochloride capsule, extended release


  1. Patient Information
  2. Do Not Take Adhansia Xr If You Or Your Child Are:
  3. What Should Be Avoided During Treatment With Adhansia Xr?
  4. Adhansia Xr Can Cause Serious Side Effects, Including:
  5. How Should I Store Adhansia Xr?
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Manufactured By:
  9. Revised: 7/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Controlled Substance Status/High Potential for Abuse and Dependence
Advise patients and their caregivers that ADHANSIA XR is a federally controlled substance, and it can be abused and lead to dependence[
ADHANSIA XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. ADHANSIA XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.
It is not known if ADHANSIA XR is safe and effective in children under 6 years of age.
ADHANSIA XR is a federally controlled substance (CII) because it contains methylphenidate that can be a target for people who abuse prescription medicines or street drugs.Keep ADHANSIA XR in a safe place to protect it from theft. Never give your ADHANSIA XR to anyone else, because it may cause death or harm them. Selling or giving away ADHANSIA XR may harm others and is against the law.

Do Not Take Adhansia Xr If You Or Your Child Are: 


  • allergic to methylphenidate hydrochloride or any of the ingredients in ADHANSIA XR.
    • Take ADHANSIA XR exactly as prescribed by your healthcare provider.
    • Your healthcare provider may change the dose if needed.
    • Take ADHANSIA XR by mouth 1 time each day in the morning.
    • ADHANSIA XR can be taken with or without food, but take it the same way each time.
      • Swallow ADHANSIA XR capsules whole. If ADHANSIA XR capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto a tablespoonful of applesauce or yogurt. Make sure to sprinkle all the medicine onto the applesauce or yogurt. The ADHANSIA XR dose should not be divided.
        • swallow all the applesauce or yogurt and medicine mixture without chewing right away or within 10 minutes
        • do notchew the applesauce or yogurt
        • do notstore applesauce or yogurt and medicine mixture
    • Your healthcare provider may sometimes stop ADHANSIA XR treatment for a while to check ADHD symptoms.
    • If a dose of ADHANSIA XR is missed do not take the dose later in the day or take an extra dose to make up for the missed dose, wait until the next morning to take the next scheduled dose.
    In case of poisoning call your poison control center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What Should Be Avoided During Treatment With Adhansia Xr? 


Avoid drinking alcohol during treatment with ADHANSIA XR. This may cause a faster release of the ADHANSIA XR medicine.

Adhansia Xr Can Cause Serious Side Effects, Including: 

  • Painful and prolonged erections (priapism).Priapism has happened in males who take products that contain methylphenidate.If you or your child develop priapism, get medical help right away.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud s phenomenon).Signs and symptoms may include:
    • fingers or toes may feel numb, cool, painful
    • fingers or toes may change color from pale, to blue, to red
    Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
    Call your healthcare provider right away if your child have any signs of unexplained wounds appearing on fingers or toes during treatment with ADHANSIA XR.
  • Slowing of growth (height and weight) in children.Children should have their height and weight checked often while taking ADHANSIA XR. ADHANSIA XR treatment may be stopped if your child is not growing or gaining weight.
  • FD&C Yellow No. 5.ADHANSIA XR 45 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.
The most common side effects in adults includetrouble sleeping, dry mouth, and decreased appetite.
The most common side effects of ADHANSIA XR in children includedecreased appetite, trouble sleeping, and decreased weight.
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 Adhansia Xr? 

  • Store ADHANSIA XR at room temperature between 68 F to 77 F (20 C to 25 C).
  • Store ADHANSIA XR in a safe place, like a locked cabinet. Protect from light and moisture.
  • Dispose of remaining, unused, or expired ADHANSIA XR by a medication take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix ADHANSIA XR with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away ADHANSIA XR in the household trash.
Keep ADHANSIA XR and all medicines out of the reach of children.General information about the safe and effective use of ADHANSIA XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ADHANSIA XR for a condition for which it was not prescribed. Do not give ADHANSIA XR to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about ADHANSIA XR that was written for healthcare professionals.

Active Ingredient: 

methylphenidate hydrochloride

Inactive Ingredients: 

ammonio methacrylate copolymer dispersion (type B), anionic copolymer (consisting of methyl acrylate, methyl methacrylate and methacrylic acid), glyceryl monostearate, hypromellose, poylethylene glycol, polysorbate, silicon dioxide, sodium hydroxide, sodium laurylsulfate, sorbic acid, sugar spheres, triethyl citrate

Manufactured By: 

Purdue Pharmaceuticals L.P., Wilson, NC 27893
To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

ADHANSIA XR 25 mg
NDC: 72912-525-30

25 mg label

ADHANSIA XR 35 mg
NDC: 72912-535-30

35 mg label

ADHANSIA XR 45 mg
NDC: 72912-545-30

45 mg label

ADHANSIA XR 55 mg
NDC: 72912-555-30

55 mg label

ADHANSIA XR 70 mg
NDC: 72912-570-30

70 mg label

ADHANSIA XR 85 mg
NDC: 72912-585-30

85 mg label
ADHANSIA XR
methylphenidate hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72912-525
Route of AdministrationORALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)METHYLPHENIDATE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeMLR02;25mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72912-525-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21203807/01/2019
ADHANSIA XR
methylphenidate hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72912-535
Route of AdministrationORALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)METHYLPHENIDATE HYDROCHLORIDE35 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
ColorORANGEScoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeMLR02;35mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72912-535-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21203807/01/2019
ADHANSIA XR
methylphenidate hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72912-545
Route of AdministrationORALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)METHYLPHENIDATE HYDROCHLORIDE45 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
Product Characteristics
ColorYELLOWScoreno score
ShapeCAPSULESize22mm
FlavorImprint CodeMLR02;45mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72912-545-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21203807/01/2019
ADHANSIA XR
methylphenidate hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72912-555
Route of AdministrationORALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)METHYLPHENIDATE HYDROCHLORIDE55 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULESize24mm
FlavorImprint CodeMLR02;55mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72912-555-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21203807/01/2019
ADHANSIA XR
methylphenidate hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72912-570
Route of AdministrationORALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)METHYLPHENIDATE HYDROCHLORIDE70 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Product Characteristics
ColorGRAYScoreno score
ShapeCAPSULESize24mm
FlavorImprint CodeMLR02;70mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72912-570-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21203807/01/2019
ADHANSIA XR
methylphenidate hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72912-585
Route of AdministrationORALDEA ScheduleCII
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)METHYLPHENIDATE HYDROCHLORIDE85 mg
Inactive Ingredients
Ingredient NameStrength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 20(UNII: 7T1F30V5YH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SORBIC ACID(UNII: X045WJ989B)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize25mm
FlavorImprint CodeMLR02;85mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72912-585-3030 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21203807/01/2019
Labeler -Adlon Therapeutics L.P. (116933715)
Registrant -Adlon Therapeutics L.P. (116933715)
Establishment
NameAddressID/FEIBusiness Operations
Glatt Air Techniques790220628MANUFACTURE(72912-535, 72912-585, 72912-525, 72912-545, 72912-570, 72912-555)
Establishment
NameAddressID/FEIBusiness Operations
Purdue Pharmaceutical Products LP132080875MANUFACTURE(72912-535, 72912-585, 72912-525, 72912-545, 72912-570, 72912-555)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Pharmaceuticals, Inc.080236951API MANUFACTURE(72912-525, 72912-535, 72912-585, 72912-555, 72912-570, 72912-545)
Establishment
NameAddressID/FEIBusiness Operations
Noramco, Inc.166506142API MANUFACTURE(72912-525, 72912-535, 72912-585, 72912-555, 72912-570, 72912-545)
Establishment
NameAddressID/FEIBusiness Operations
Rhodes Technologies, Inc157990263API MANUFACTURE(72912-525, 72912-535, 72912-585, 72912-555, 72912-570, 72912-545)

Revised: 7/2019document Id: 

69c48eb6-8ae5-9083-0e1f-22db17d38604Set id: 80e15bd0-4d56-75f0-ab5a-885879fc56e9Version: 8Effective Time: 20190701Adlon Therapeutics L.P.



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