65862-829 : Prasugrel 5 mg Oral Tablet, Film Coated


NDC65862-829
Labeler: Aurobindo Pharma Limited
Product Type: Human Prescription Drug
Drug Name:  Prasugrel
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA205888
Rev. Date: 


Appearance:


Markings: I;23
Shapes:  Hexagon (6 sides)
Colors:  Yellow
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:

  • 65862-829-03: 3 BLISTER PACK IN 1 CARTON (65862‑829‑03) > 10 TABLET, FILM COATED IN 1 BLISTER PACK (65862‑829‑10)
  • 65862-829-30: 30 TABLET, FILM COATED IN 1 BOTTLE (65862‑829‑30)

Active Ingredients:

  • Prasugrel Hydrochloride

Dosage Strength:

  • 5 mg

Inactive Ingredients:

  • Glyceryl Dibehenate
  • Hypromellose 2910 (5 Mpa.s)
  • Hypromellose 2910 (6 Mpa.s)
  • Lactose Monohydrate
  • Low-substituted Hydroxypropyl Cellulose, Unspecified
  • Mannitol
  • Microcrystalline Cellulose
  • Sucrose Stearate
  • Titanium Dioxide
  • Triacetin
  • Ferric Oxide Yellow

Pharmaceutical Classes:

  • Decreased Platelet Aggregation [PE]
  • P2Y12 Platelet Inhibitor [EPC]
  • P2Y12 Receptor Antagonists [MoA]

Related Products:

Based on records with the same trade name.
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  • 0378-5185 Prasugrel 5 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
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  • 16729-272 Prasugrel 5 mg Oral Tablet, Film Coated by Accord Healthcare Inc.
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  • 65162-001 Prasugrel 5 mg Oral Tablet, Film Coated by Amneal Pharmaceuticals LLC
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  • 66993-575 Prasugrel 5 mg Oral Tablet, Film Coated by Prasco Laboratories
  • 66993-576 Prasugrel 10 mg Oral Tablet, Film Coated by Prasco Laboratories
  • 67877-604 Prasugrel 5 mg Oral Tablet, Film Coated by Ascend Laboratories, LLC
  • 67877-605 Prasugrel 10 mg Oral Tablet, Film Coated by Ascend Laboratories, LLC

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Notice: The MedsChat® NDC Database compiles 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.


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