42794-052 : Ambrisentan 10 mg Oral Tablet, Film Coated


NDC: 42794-052
Labeler: Sigmapharm Laboratories, LLC
Product Type: Human Prescription Drug
Drug Name:  Ambrisentan
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA208354
Rev. Date: 


Appearance:


Markings: 52
Shapes:  Oval
Colors:  Pink
Size (mm): 10
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:

  • 42794-052-08: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (42794‑052‑08)
  • 42794-052-22: 10 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (42794‑052‑22)

Active Ingredients:

  • Ambrisentan

Dosage Strength:

  • 10 mg

Inactive Ingredients:

  • Croscarmellose Sodium
  • Lactose Monohydrate
  • Magnesium Stearate
  • Cellulose, Microcrystalline
  • Fd&c Red No. 40
  • Aluminum Oxide
  • Polyethylene Glycol 3350
  • Polyvinyl Alcohol
  • Talc
  • Titanium Dioxide /

Pharmaceutical Classes:

  • Endothelin Receptor Antagonist [EPC]
  • Endothelin Receptor Antagonists [MoA]

Related Products:

Based on records with the same trade name.
  • 42794-051 Ambrisentan 5 mg Oral Tablet, Film Coated by Sigmapharm Laboratories, LLC
  • 0378-4270 Ambrisentan 5 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0378-4271 Ambrisentan 10 mg Oral Tablet, Film Coated by Mylan Pharmaceuticals Inc.
  • 0591-2405 Ambrisentan 5 mg Oral Tablet, Film Coated by Actavis Pharma, Inc.
  • 0591-2406 Ambrisentan 10 mg Oral Tablet, Film Coated by Actavis Pharma, Inc.
  • 42291-018 Ambrisentan 5 mg Oral Tablet, Film Coated by Avkare
  • 42291-019 Ambrisentan 10 mg Oral Tablet, Film Coated by Avkare
  • 47335-236 Ambrisentan 5 mg Oral Tablet, Film Coated by Sun Pharmaceutical Industries, Inc.
  • 47335-237 Ambrisentan 10 mg Oral Tablet, Film Coated by Sun Pharmaceutical Industries, Inc.
  • 49884-353 Ambrisentan 5 mg Oral Tablet, Film Coated by Par Pharmaceutical, Inc.
  • 49884-354 Ambrisentan 10 mg Oral Tablet, Film Coated by Par Pharmaceutical, Inc.
  • 59651-494 Ambrisentan 5 mg Oral Tablet, Film Coated by Aurobindo Pharma Limited
  • 59651-495 Ambrisentan 10 mg Oral Tablet, Film Coated by Aurobindo Pharma Limited
  • 60505-4552 Ambrisentan 5 mg Oral Tablet, Film Coated by Apotex Corp.
  • 60505-4553 Ambrisentan 10 mg Oral Tablet, Film Coated by Apotex Corp.
  • 69097-386 Ambrisentan 5 mg Oral Tablet, Film Coated by Cipla USA Inc.
  • 69097-387 Ambrisentan 10 mg Oral Tablet, Film Coated by Cipla USA Inc.
  • 70710-1179 Ambrisentan 5 mg Oral Tablet, Film Coated by Zydus Pharmaceuticals (Usa) Inc.
  • 70710-1180 Ambrisentan 10 mg Oral Tablet, Film Coated by Zydus Pharmaceuticals (Usa) Inc.
  • 70771-1363 Ambrisentan 5 mg Oral Tablet, Film Coated by Cadila Healthcare Limited
  • More related products ...

NDC QR Code

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Related Discussions:

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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.