54868-5397 : Metadate Cd 10 mg 24 Hr Extended Release Capsule


NDC54868-5397
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Metadate Cd
Dosage Form: Oral Capsule, Extended Release
Application #: NDA021259
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: UCB;579;10;mg
Shapes:  Capsule
Colors:  White / Green
Size (mm): 14
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:

  • 54868-5397-0: 30 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5397‑0)
  • 54868-5397-1: 10 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE, PLASTIC (54868‑5397‑1)

Active Ingredients:

  • Methylphenidate Hydrochloride

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Povidone
  • Hypromelloses
  • Polyethylene Glycol
  • Ethylcelluloses
  • Dibutyl Sebacate
  • Gelatin
  • Titanium Dioxide
  • Fd&c Blue No. 2
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54868-0668 Metadate Cd 30 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.
  • 54868-4718 Metadate Cd 20 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.
  • 54868-6234 Metadate 50 mg 24 Hr Extended Release Capsule by Physicians Total Care, Inc.
  • 53014-579 Metadate Cd 10 mg 24 Hr Extended Release Capsule by Unither Manufacturing, LLC
  • 53014-580 Metadate Cd 20 mg 24 Hr Extended Release Capsule by Unither Manufacturing, LLC
  • 53014-581 Metadate Cd 30 mg 24 Hr Extended Release Capsule by Unither Manufacturing, LLC
  • 53014-582 24 Hr Metadate 40 mg Extended Release Capsule by Unither Manufacturing, LLC
  • 53014-583 Metadate 50 mg 24 Hr Extended Release Capsule by Unither Manufacturing, LLC
  • 53014-584 24 Hr Metadate 60 mg Extended Release Capsule by Unither Manufacturing, LLC
  • 65084-466 Metadate Cd 40 mg Oral Capsule, Extended Release by Rxpak Division of Mckesson Corp
  • 65084-467 Metadate Cd 10 mg Oral Capsule, Extended Release by Rxpak Division of Mckesson Corp
  • 65084-468 Metadate Cd 20 mg Oral Capsule, Extended Release by Rxpak Division of Mckesson Corp
  • 65084-469 Metadate Cd 30 mg Oral Capsule, Extended Release by Rxpak Division of Mckesson Corp
  • 69654-579 Metadate Cd 10 mg Oral Capsule, Extended Release by Aytu Biopharma, Inc.
  • 69654-580 Metadate Cd 20 mg Oral Capsule, Extended Release by Aytu Biopharma, Inc.
  • 69654-581 Metadate Cd 30 mg Oral Capsule, Extended Release by Aytu Biopharma, Inc.
  • 69654-582 Metadate Cd 40 mg Oral Capsule, Extended Release by Aytu Biopharma, Inc.
  • 69654-583 Metadate Cd 50 mg Oral Capsule, Extended Release by Aytu Biopharma, Inc.
  • 69654-584 Metadate Cd 60 mg Oral Capsule, Extended Release by Aytu Biopharma, Inc.

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.