65862-862 : Darifenacin 15 mg Oral Tablet, Film Coated, Extended Release


NDC: 65862-862
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Darifenacin
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA206743
Rev. Date: 


Appearance:


Markings: Z;23
Shapes:  Round
Colors:  Orange
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:

  • 65862-862-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑862‑05)
  • 65862-862-30: 30 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑862‑30)
  • 65862-862-90: 90 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑862‑90)
  • 65862-862-99: 1000 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑862‑99)

Active Ingredients:

  • Darifenacin Hydrobromide

Dosage Strength:

  • 15 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Dibasic Calcium Phosphate Dihydrate
  • Ethylcellulose (10 Mpa.s)
  • Hydroxyethyl Cellulose (4000 Mpa.s At 1%)
  • Hydroxypropyl Cellulose
  • Hypromellose 2910 (5 Mpa.s)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Polyethylene Glycol 6000
  • Povidone K30
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Red
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 65862-861 Darifenacin 7.5 mg Oral Tablet, Film Coated, Extended Release by Aurobindo Pharma Limited
  • 0591-4375 Darifenacin 7.5 mg Oral Tablet, Extended Release by Actavis Pharma, Inc.
  • 0591-4380 Darifenacin 15 mg Oral Tablet, Extended Release by Actavis Pharma, Inc.
  • 13668-202 Darifenacin 7.5 mg Oral Tablet, Extended Release by Torrent Pharmaceuticals Limited
  • 13668-203 Darifenacin 15 mg Oral Tablet, Extended Release by Torrent Pharmaceuticals Limited
  • 16571-767 Darifenacin 7.5 mg Oral Tablet, Film Coated, Extended Release by Rising Pharma Holdings, Inc.
  • 16571-768 Darifenacin 15 mg Oral Tablet, Film Coated, Extended Release by Rising Pharma Holdings, Inc.
  • 33342-276 Darifenacin 7.5 mg Oral Tablet, Extended Release by Macleods Pharmaceuticals Limited
  • 33342-277 Darifenacin 15 mg Oral Tablet, Extended Release by Macleods Pharmaceuticals Limited
  • 46708-223 Darifenacin 7.5 mg Oral Tablet, Extended Release by Alembic Pharmaceuticals Limited
  • 46708-224 Darifenacin 15 mg Oral Tablet, Extended Release by Alembic Pharmaceuticals Limited
  • 52605-067 Darifenacin 7.5 mg Oral Tablet, Extended Release by Polygen Pharmaceuticals Inc.
  • 52605-068 Darifenacin 15 mg Oral Tablet, Extended Release by Polygen Pharmaceuticals Inc.
  • 59746-516 Darifenacin 7.5 mg Oral Tablet, Extended Release by Jubilant Cadista Pharmaceuticals Inc.
  • 59746-517 Darifenacin 15 mg Oral Tablet, Extended Release by Jubilant Cadista Pharmaceuticals Inc.
  • 62332-223 Darifenacin 7.5 mg Oral Tablet, Extended Release by Alembic Pharmaceuticals Inc.
  • 62332-224 Darifenacin 15 mg Oral Tablet, Extended Release by Alembic Pharmaceuticals Inc.
  • 69097-431 Darifenacin 7.5 mg Oral Tablet, Extended Release by Cipla USA Inc.
  • 69097-432 Darifenacin 15 mg Oral Tablet, Extended Release by Cipla USA 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.