65862-863 : Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release


NDC: 65862-863
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Dalfampridine
Dosage Form: Oral Tablet, Film Coated, Extended Release
Application #: ANDA206811
Rev. Date: 


Appearance:


Markings: J;76
Shapes:  Oval
Colors:  White
Size (mm): 13
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:

  • 65862-863-01: 100 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑863‑01)
  • 65862-863-05: 500 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑863‑05)
  • 65862-863-60: 60 TABLET, FILM COATED, EXTENDED RELEASE IN 1 BOTTLE (65862‑863‑60)

Active Ingredients:

  • Dalfampridine

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Hypromellose 2910 (5 Mpa.s)
  • Hypromellose 2208 (100 Mpa.s)
  • Magnesium Stearate
  • Microcrystalline Cellulose
  • Polyethylene Glycol 400
  • Talc
  • Titanium Dioxide /

Pharmaceutical Classes:

  • Potassium Channel Blocker [EPC]
  • Potassium Channel Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0054-0479 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by West-ward Pharmaceuticals Corp.
  • 0378-0509 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Mylan Pharmaceuticals Inc.
  • 0378-4504 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Mylan Pharmaceuticals Inc.
  • 0591-2533 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Actavis Pharma, Inc.
  • 16729-292 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Accord Healthcare Inc.
  • 42571-275 Dalfampridine 10 mg Oral Tablet, Extended Release by Micro Labs Limited
  • 51407-246 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply, Inc.
  • 51407-876 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Golden State Medical Supply, Inc.
  • 62756-429 Dalfampridine 10 mg Oral Tablet, Extended Release by Sun Pharmaceutical Industries, Inc.
  • 63629-9450 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Bryant Ranch Prepack
  • 67877-444 Dalfampridine 10 mg Oral Tablet, Film Coated, Extended Release by Ascend Laboratories, LLC

NDC QR Code

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NDC 65862-863 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.