Search by Drug Name or NDC

NDC 68180-0386-07 Bosentan 125 mg/1 Details

Bosentan 125 mg/1

Bosentan is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is BOSENTAN.

MedlinePlus Drug Summary

Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. Bosentan may improve the ability to exercise and slow the worsening of symptoms in patients with PAH. Bosentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.

Related Packages: 68180-0386-07
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bosentan

Product Information

NDC	68180-0386
Product ID	68180-386_84808826-8dba-4542-a1eb-fe1b77183e58
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Bosentan
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bosentan
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	125
Active Ingredient Units	mg/1
Substance Name	BOSENTAN
Labeler Name	Lupin Pharmaceuticals, Inc.
Pharmaceutical Class	Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA206987
Listing Certified Through	2022-12-31

Package

NDC 68180-0386-07 (68180038607)

Pricing Information	N/A
NDC Package Code	68180-386-07
Billing NDC	68180038607
Package	60 TABLET in 1 BOTTLE (68180-386-07)
Marketing Start Date	2019-04-26
NDC Exclude Flag	N