46708-384 : Bosentan 125 mg Oral Tablet, Film Coated


NDC: 46708-384
Labeler: Alembic Pharmaceuticals Limited
Product Type: Human Prescription Drug
Drug Name:  Bosentan
Dosage Form: Oral Tablet, Film Coated
Application #: ANDA211461
Rev. Date: 


Appearance:


Markings: L420
Shapes:  Oval
Colors:  Orange
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:

  • 46708-384-10: 100 TABLET, FILM COATED IN 1 CARTON (46708‑384‑10)
  • 46708-384-60: 60 TABLET, FILM COATED IN 1 BOTTLE (46708‑384‑60)

Active Ingredients:

  • Bosentan

Dosage Strength:

  • 125 mg

Inactive Ingredients:

  • Starch, Pregelatinized Corn
  • Povidone K30
  • Sodium Starch Glycolate Type a Potato
  • Glyceryl Dibehenate
  • Magnesium Stearate
  • Hypromelloses
  • Titanium Dioxide
  • Triacetin
  • Talc
  • Ethylcellulose, Unspecified
  • Ferric Oxide Yellow
  • Ferric Oxide Red /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 46708-383 Bosentan 62.5 mg Oral Tablet, Film Coated by Alembic Pharmaceuticals Limited
  • 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.
  • 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.
  • 68180-387 Bosentan 62.5 mg Oral Tablet by Lupin Pharmaceuticals, Inc.
  • 68382-446 Bosentan 62.5 mg Oral Tablet, Coated by Zydus Pharmaceuticals (Usa) Inc.
  • More related products ...

NDC QR Code

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NDC 46708-384 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.