69097-378 : Bosentan 125 mg Oral Tablet, Film Coated


NDC: 69097-378
Labeler: Cipla USA Inc.
Product Type: Human Prescription Drug
Drug Name:  Bosentan
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA210342
Rev. Date: 


Appearance:


Markings: C378
Shapes:  Oval
Colors:  Yellow
Size (mm): 11
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:

  • 69097-378-03: 60 TABLET, FILM COATED IN 1 BOTTLE (69097‑378‑03)
  • 69097-378-76: 1 BLISTER PACK IN 1 CARTON (69097‑378‑76) > 14 TABLET, FILM COATED IN 1 BLISTER PACK

Active Ingredients:

  • Bosentan

Dosage Strength:

  • 125 mg

Inactive Ingredients:

  • Povidone K30
  • Glyceryl Behenate/Eicosadioate
  • Magnesium Stearate
  • Hypromellose, Unspecified
  • Triacetin
  • Talc
  • Titanium Dioxide
  • Ferric Oxide Yellow
  • Ferric Oxide Red
  • Ethylcellulose, Unspecified
  • Sodium Starch Glycolate Type B Potato
  • Starch, Corn /

Pharmaceutical Classes:

  • Endothelin Receptor Antagonist [EPC]
  • Endothelin Receptor Antagonists [MoA]
  • Cytochrome P450 3A Inducers [MoA]
  • Cytochrome P450 2C9 Inducers [MoA]

Related Products:

Based on records with the same trade name.
  • 69097-377 Bosentan 62.5 mg Oral Tablet, Film Coated by Cipla USA Inc.
  • 0054-0520 Bosentan 62.5 mg Oral Tablet by West-ward Pharmaceuticals Corp.
  • 0054-0521 Bosentan 125 mg Oral Tablet by West-ward Pharmaceuticals Corp.
  • 0591-2511 Bosentan 62.5 mg Oral Tablet, Film Coated by Actavis Pharma, Inc.
  • 0591-2512 Bosentan 125 mg Oral Tablet, Film Coated by Actavis Pharma, Inc.
  • 10148-125 Bosentan 125 mg Oral Tablet, Film Coated by Cotherix, Inc.
  • 10148-625 Bosentan 62.5 mg Oral Tablet, Film Coated by Cotherix, Inc.
  • 46708-383 Bosentan 62.5 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Limited
  • 46708-384 Bosentan 125 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Limited
  • 47335-038 Bosentan 62.5 mg Oral Tablet, Film Coated by Sun Pharmaceutical Industries, Inc.
  • 47335-039 Bosentan 125 mg Oral Tablet, Film Coated by Sun Pharmaceutical Industries, Inc.
  • 47781-270 Bosentan 62.5 mg Oral Tablet, Film Coated by Alvogen Inc.
  • 47781-271 Bosentan 125 mg Oral Tablet, Film Coated by Alvogen Inc.
  • 49884-058 Bosentan 62.5 mg Oral Tablet, Film Coated by Par Pharmaceutical, Inc.
  • 49884-059 Bosentan 125 mg Oral Tablet, Film Coated by Par Pharmaceutical, Inc.
  • 62332-383 Bosentan 62.5 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Inc.
  • 62332-384 Bosentan 125 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Inc.
  • 65162-873 Bosentan 62.5 mg Oral Tablet, Film Coated by Amneal Pharmaceuticals LLC
  • 65162-874 Bosentan 125 mg Oral Tablet, Film Coated by Amneal Pharmaceuticals LLC
  • 68180-386 Bosentan 125 mg Oral Tablet by Lupin Pharmaceuticals, Inc.
  • More related products ...

NDC QR Code

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NDC 69097-378 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.