42291-207 : Darifenacin Hydrobromide Extended-release 15 mg Oral Tablet, Extended Release


NDC: 42291-207
Labeler: Avkare, Inc.
Product Type: Human Prescription Drug
Drug Name:  Darifenacin Hydrobromide Extended-release
Dosage Form: Oral Tablet, Extended Release
Application #: ANDA091190
Rev. Date: 


Appearance:


Markings: C171
Shapes:  Round
Colors:  White
Size (mm): 8
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:

  • 42291-207-90: 90 TABLET, EXTENDED RELEASE IN 1 BOTTLE (42291‑207‑90)

Active Ingredients:

  • Darifenacin Hydrobromide

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Calcium Phosphate, Dibasic, Anhydrous
  • Hypromellose 2208 (3 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Water
  • Polyvinyl Alcohol, Unspecified
  • Polyethylene Glycols
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 42291-206 Darifenacin Hydrobromide Extended-release 7.5 mg Oral Tablet, Extended Release by Avkare, Inc.
  • 10370-170 Darifenacin Hydrobromide Extended-release 7.5 mg Oral Tablet, Extended Release by Par Pharmaceutical
  • 10370-171 Darifenacin Hydrobromide Extended-release 15 mg Oral Tablet, Extended Release by Par Pharmaceutical
  • 60429-850 Darifenacin Hydrobromide Extended-release 7.5 mg Oral Tablet, Extended Release by Golden State Medical Supply, Inc.
  • 60429-851 Darifenacin Hydrobromide Extended-release 15 mg Oral Tablet, Extended Release by Golden State Medical Supply, 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.