0115-1565 : Teriflunomide 14 mg Oral Tablet, Film Coated


NDC: 0115-1565
Labeler: Amneal Pharmaceuticals of New York LLC
Product Type: Human Prescription Drug
Drug Name:  Teriflunomide
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA209677
Rev. Date: 


Appearance:


Markings: 14
Shapes:  Round
Colors:  Blue
Size (mm): 7
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:

  • 0115-1565-44: 28 TABLET, FILM COATED IN 1 CARTON (0115‑1565‑44)

Active Ingredients:

  • Teriflunomide

Dosage Strength:

  • 14 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Hydroxypropyl Cellulose (90000 Wamw)
  • Microcrystalline Cellulose
  • Silicon Dioxide
  • Magnesium Stearate
  • Titanium Dioxide
  • Talc
  • Hypromellose 2910 (6 Mpa.s)
  • Hydrogenated Cottonseed Oil
  • Fd&c Blue No. 2
  • Fd&c Red No. 40 /

Pharmaceutical Classes:

  • Dihydroorotate Dehydrogenase Inhibitors [MoA]
  • Pyrimidine Synthesis Inhibitor [EPC]

Related Products:

Based on records with the same trade name.
  • 0378-0627 Teriflunomide 7 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
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  • 0480-3157 Teriflunomide 7 mg Oral Tablet, Film Coated by Teva Pharmaceuticals, Inc.
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  • 0781-5755 Teriflunomide 14 mg Oral Tablet, Film Coated by Sandoz Inc
  • 16729-399 Teriflunomide 7 mg Oral Tablet, Film Coated by Accord Healthcare Inc.
  • 16729-400 Teriflunomide 14 mg Oral Tablet, Film Coated by Accord Healthcare Inc.
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  • 31722-247 Teriflunomide 14 mg Oral Tablet, Film Coated by Camber Pharmaceuticals, Inc.
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  • 42291-831 Teriflunomide 14 mg Oral Tablet, Film Coated by Avkare
  • 43598-281 Teriflunomide 14 mg Oral Tablet, Film Coated by Dr. Reddy's Laboratories Inc
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  • 46708-313 Teriflunomide 7 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Limited
  • 46708-314 Teriflunomide 14 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Limited
  • 51991-881 Teriflunomide 7 mg Oral Tablet by Breckenridge Pharmaceutical, Inc.
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  • 59651-054 Teriflunomide 7 mg Oral Tablet by Aurobindo Pharma Limited
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  • More related products ...

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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.