54766-200 : Motofen Oral Tablet


NDC: 54766-200
Labeler: Sebela Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Motofen
Dosage Form: Oral Tablet
Application #: NDA017744
Rev. Date: 
CSA Schedule: CIV (US) [1]


[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: 0200;M
Shapes:  Pentagon (5 sides)
Colors:  White
Size (mm): 7
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 54766-200-04: 4 TABLET IN 1 BLISTER PACK (54766‑200‑04)
  • 54766-200-10: 100 TABLET IN 1 BOTTLE (54766‑200‑10)

Active Ingredients:

  • Atropine Sulfate
  • Difenoxin Hydrochloride

Dosage Strength:

  • .025 mg
  • 1 mg

Inactive Ingredients:

  • Calcium Stearate
  • Starch, Corn
  • Cellulose, Microcrystalline
  • Anhydrous Lactose

Pharmaceutical Classes:

  • Anticholinergic [EPC]
  • Antidiarrheal [EPC]
  • Cholinergic Antagonists [MoA]
  • Cholinergic Muscarinic Antagonist [EPC]
  • Cholinergic Muscarinic Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0187-0500 Motofen (Atropine Sulfate 0.025 mg / Difenoxin Hydrochloride 1 mg) Oral Tablet by Valeant Pharmaceuticals North America LLC

NDC QR Code

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NDC 54766-200 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.