0093-5348 : Methylphenidate Hydrochloride 40 mg 24 Hr Extended Release Capsule


NDC0093-5348
Labeler: Teva Pharmaceuticals USA Inc
Product Type: Human Prescription Drug
Drug Name:  Methylphenidate Hydrochloride
Dosage Form: Oral Capsule, Extended Release
Application #: ANDA079031
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: TEVA;5348
Shapes:  Capsule
Colors:  Brown
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:

  • 0093-5348-01: 100 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (0093‑5348‑01)

Active Ingredients:

  • Methylphenidate Hydrochloride

Dosage Strength:

  • 40 mg

Inactive Ingredients:

  • Ammonio Methacrylate Copolymer Type B
  • Ferrosoferric Oxide
  • D&c Yellow No. 10
  • Aluminum Oxide
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Gelatin
  • Hypromellose 2208 (3 Mpa.s)
  • Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)
  • Polyethylene Glycol 6000
  • Propylene Glycol
  • Shellac
  • Starch, Corn
  • Sucrose
  • Talc
  • Titanium Dioxide
  • Triethyl Citrate
  • Fd&c Yellow No. 6

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0093-5292 Methylphenidate Hydrochloride 50 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5293 Methylphenidate Hydrochloride 60 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5295 Methylphenidate Hydrochloride 10 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5296 Methylphenidate Hydrochloride 20 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5297 Methylphenidate Hydrochloride 30 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5298 Methylphenidate Hydrochloride 40 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5346 Methylphenidate Hydrochloride 20 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0093-5347 Methylphenidate Hydrochloride 30 mg 24 Hr Extended Release Capsule by Teva Pharmaceuticals USA Inc
  • 0115-1566 Methylphenidate Hydrochloride by Impax Generics
  • 0115-1567 Methylphenidate Hydrochloride by Impax Generics
  • 0115-1568 Methylphenidate Hydrochloride by Impax Generics
  • 0115-1569 Methylphenidate Hydrochloride by Impax Generics
  • 0115-1736 Methylphenidate Hydrochloride 10 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1737 Methylphenidate Hydrochloride 20 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1738 Methylphenidate Hydrochloride 30 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1739 Methylphenidate Hydrochloride 40 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1740 Methylphenidate Hydrochloride 50 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1741 Methylphenidate Hydrochloride 60 mg Oral Capsule, Extended Release by Impax Generics
  • 0115-1800 Methylphenidate Hydrochloride 5 mg Oral Tablet by Impax Generics
  • 0115-1801 Methylphenidate Hydrochloride 10 mg Oral Tablet by Impax Generics
  • More related products ...

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.