72912-525 : Adhansia XR 25 mg Oral Capsule, Extended Release


NDC72912-525
Labeler: Adlon Therapeutics L.p.
Product Type: Human Prescription Drug
Drug Name:  Adhansia XR
Dosage Form: Oral Capsule, Extended Release
Application #: NDA212038
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: MLR02;25mg
Shapes:  Capsule
Colors:  Blue
Size (mm): 18
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 72912-525-30: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (72912‑525‑30)

Active Ingredients:

  • Methylphenidate Hydrochloride

Dosage Strength:

  • 25 mg

Inactive Ingredients:

  • Ammonio Methacrylate Copolymer Type B
  • Fd&c Blue No. 1
  • Glyceryl Monostearate
  • Hypromellose, Unspecified
  • Polyethylene Glycol, Unspecified
  • Polysorbate 20
  • Silicon Dioxide
  • Sodium Hydroxide
  • Sodium Lauryl Sulfate
  • Sorbic Acid
  • Sucrose
  • Starch, Corn
  • Triethyl Citrate /

Pharmaceutical Classes:

  • Central Nervous System Stimulant [EPC]
  • Central Nervous System Stimulation [PE]

Related Products:

Based on records with the same trade name.
  • 72912-535 Adhansia XR 35 mg Oral Capsule, Extended Release by Adlon Therapeutics L.p.
  • 72912-545 Adhansia XR 45 mg Oral Capsule, Extended Release by Adlon Therapeutics L.p.
  • 72912-555 Adhansia XR 55 mg Oral Capsule, Extended Release by Adlon Therapeutics L.p.
  • 72912-570 Adhansia XR 70 mg Oral Capsule, Extended Release by Adlon Therapeutics L.p.
  • 72912-585 Adhansia XR 85 mg Oral Capsule, Extended Release by Adlon Therapeutics L.p.

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.