58468-0211 : Aubagio 7 mg Oral Tablet


NDC58468-0211
Labeler: Genzyme Corp.
Product Type: Human Prescription Drug
Drug Name:  Aubagio
Dosage Form: Oral Tablet, Film Coated
Application #: NDA202992
Rev. Date: 


Appearance:


Markings: 7
Shapes:  Hexagon (6 sides)
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:

  • 58468-0211-1: 2 BLISTER PACK IN 1 CARTON (58468‑0211‑1) > 14 TABLET, FILM COATED IN 1 BLISTER PACK
  • 58468-0211-2: 1 BLISTER PACK IN 1 CARTON (58468‑0211‑2) > 5 TABLET, FILM COATED IN 1 BLISTER PACK
  • 58468-0211-3: 1 BLISTER PACK IN 1 CARTON (58468‑0211‑3) > 5 TABLET, FILM COATED IN 1 BLISTER PACK
  • 58468-0211-4: 1 BOTTLE IN 1 CARTON (58468‑0211‑4) > 30 TABLET, FILM COATED IN 1 BOTTLE

Active Ingredients:

  • Teriflunomide

Dosage Strength:

  • 7 mg

Inactive Ingredients:

  • Lactose Monohydrate
  • Starch, Corn
  • Hydroxypropyl Cellulose
  • Cellulose, Microcrystalline
  • Sodium Starch Glycolate Type a Corn
  • Magnesium Stearate
  • Hypromelloses
  • Titanium Dioxide
  • Talc
  • Polyethylene Glycols
  • Fd&c Blue No. 2
  • Ferric Oxide Yellow

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 58468-0210 Aubagio 14 mg Oral Tablet by Genzyme Corp.

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.