69238-1319 : Dimethyl Fumarate 240 mg Oral Capsule, Delayed Release


NDC: 69238-1319
Labeler: Amneal Pharmaceuticals Ny LLC
Product Type: Human Prescription Drug
Drug Name: Dimethyl Fumarate
Dosage Form: Oral Capsule, Delayed Release
Application #: ANDA210402
Rev. Date: 


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 334
Shapes:  Capsule
Colors:  White
Size (mm): 15
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:

  • 68788-9968-1: 100 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑1)
  • 68788-9968-2: 20 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑2)
  • 68788-9968-3: 30 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑3)
  • 68788-9968-4: 40 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑4)
  • 68788-9968-5: 50 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑5)
  • 68788-9968-6: 60 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑6)
  • 68788-9968-8: 120 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑8)
  • 68788-9968-9: 90 TABLET, FILM COATED IN 1 BOTTLE (68788‑9968‑9)

Active Ingredients:

  • Acetaminophen
  • Tramadol Hydrochloride

Dosage Strength:

  • 325 mg
  • 37.5 mg

Inactive Ingredients:

  • Starch, Corn
  • Hypromelloses
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol 6000
  • Sodium Starch Glycolate Type a Potato
  • Talc
  • Titanium Dioxide

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

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NDC QR Code

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NDC 69238-1319 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.