49884-428 : Dexmethylphenidate Hydrochloride Extended-release 15 mg/1 Oral Capsule, Extended Release


NDC: 49884-428
Labeler: Par Pharmaceutical Inc.
Product Type: Human Prescription Drug
Drug Name:  Dexmethylphenidate Hydrochloride Extended-release
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA078992
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: par;428
Shapes:  Capsule
Colors:  White
Size (mm): 19
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:

  • 49884-428-01: 100 CAPSULE, EXTENDED RELEASE IN 1 PACKAGE (49884‑428‑01)
  • 49884-428-10: 1000 CAPSULE, EXTENDED RELEASE IN 1 PACKAGE (49884‑428‑10)

Active Ingredients:

  • Dexmethylphenidate Hydrochloride

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Sucrose
  • Silicon Dioxide
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)
  • Triethyl Citrate
  • Talc
  • Polyethylene Glycols
  • Hypromelloses
  • Polydextrose
  • Triacetin
  • Fd&c Blue No. 2
  • Fd&c Yellow No. 6
  • Titanium Dioxide
  • Gelatin

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 49884-430 Dexmethylphenidate Hydrochloride Extended-release 30 mg/1 Oral Capsule, Extended Release by Par Pharmaceutical Inc.
  • 0527-8106 Dexmethylphenidate Hydrochloride Extended-release 5 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8107 Dexmethylphenidate Hydrochloride Extended-release 10 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8108 Dexmethylphenidate Hydrochloride Extended-release 15 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8109 Dexmethylphenidate Hydrochloride Extended-release 20 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8110 Dexmethylphenidate Hydrochloride Extended-release 25 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8111 Dexmethylphenidate Hydrochloride Extended-release 30 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8112 Dexmethylphenidate Hydrochloride Extended-release 35 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0527-8113 Dexmethylphenidate Hydrochloride Extended-release 40 mg Oral Capsule, Extended Release by Lannett Company, Inc.
  • 0781-2682 Dexmethylphenidate Hydrochloride 5 mg Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2683 Dexmethylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2684 Dexmethylphenidate Hydrochloride 15 mg/1 Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2685 Dexmethylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2686 Dexmethylphenidate Hydrochloride Extended-release 25 mg Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2687 Dexmethylphenidate Hydrochloride 30 mg/1 Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2688 Dexmethylphenidate Hydrochloride Extended-release 35 mg Oral Capsule, Extended Release by Sandoz Inc
  • 0781-2689 Dexmethylphenidate Hydrochloride 40 mg/1 Oral Capsule, Extended Release by Sandoz Inc
  • 63629-2172 Dexmethylphenidate Hydrochloride Extended-release 15 mg Oral Capsule, Extended Release by Bryant Ranch Prepack
  • 63629-2175 Dexmethylphenidate Hydrochloride Extended-release 30 mg Oral Capsule, Extended Release by Bryant Ranch Prepack
  • 68084-933 Dexmethylphenidate Hydrochloride Extended-release 30 mg Oral Capsule, Extended Release by American Health Packaging
  • More related products ...

NDC QR Code

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NDC 49884-428 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.