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Bosentan

Prescription ANDA TE AB
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Bosentan
Generic name
Bosentan
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Zydus Lifesciences Limited
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
10
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Bosentan 125 mg/1 349253 View
Bosentan 62.5 mg/1 349253 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2C9 Inducers [MoA] MoA All 46 members
Cytochrome P450 3A Inducers [MoA] MoA All 37 members
Endothelin Receptor Antagonist [EPC] EPC All 10 members
Endothelin Receptor Antagonists [MoA] MoA All 10 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207760
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 26, 2019
Sponsor
ZYDUS PHARMS
Products on application
2
Submissions recorded
10
Products approved under application 207760.
Product Trade name Form Strength Ingredient Status TE Flags
207760-001 BOSENTAN TABLET BOSENTAN Prescription AB
207760-002 BOSENTAN TABLET BOSENTAN Prescription AB

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
No
Reference Standard
No

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 207760.
Type No. Action Status Date Review
Supplement 15 Labeling Approved April 14, 2026 Standard
Supplement 14 Labeling Approved April 14, 2026 Standard
Supplement 16 REMS Approved March 3, 2026 —
Supplement 13 REMS Approved November 5, 2025 —
Supplement 11 REMS Approved February 21, 2025 —
Supplement 10 REMS Approved September 17, 2024 —
Supplement 9 Labeling Approved May 30, 2024 Standard
Supplement 6 REMS Approved April 29, 2022 —
Supplement 1 Labeling Approved November 1, 2019 Standard
Original application 1 Approved April 26, 2019 Standard

Review documents

  • 0 · Original application · November 6, 2023

Adverse event reports

Source: openFDA FAERS
50,110
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: BOSENTAN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
70771-1017-1 70771-1017 Zydus Lifesciences Limited 100 TABLET in 1 BOTTLE (70771-1017-1) May 1, 2019
70771-1017-4 70771-1017 Zydus Lifesciences Limited 10 BLISTER PACK in 1 CARTON (70771-1017-4) / 10 TABLET in 1 BLISTER PACK (70771-1017-2) May 1, 2019
70771-1017-5 70771-1017 Zydus Lifesciences Limited 500 TABLET in 1 BOTTLE (70771-1017-5) May 1, 2019
70771-1017-6 70771-1017 Zydus Lifesciences Limited 60 TABLET in 1 BOTTLE (70771-1017-6) May 1, 2019
70771-1017-8 70771-1017 Zydus Lifesciences Limited 180 TABLET in 1 BOTTLE (70771-1017-8) May 1, 2019
70771-1018-1 70771-1018 Zydus Lifesciences Limited 100 TABLET in 1 BOTTLE (70771-1018-1) May 1, 2019
70771-1018-4 70771-1018 Zydus Lifesciences Limited 10 BLISTER PACK in 1 CARTON (70771-1018-4) / 10 TABLET in 1 BLISTER PACK (70771-1018-2) May 1, 2019
70771-1018-5 70771-1018 Zydus Lifesciences Limited 500 TABLET in 1 BOTTLE (70771-1018-5) May 1, 2019
70771-1018-6 70771-1018 Zydus Lifesciences Limited 60 TABLET in 1 BOTTLE (70771-1018-6) May 1, 2019
70771-1018-8 70771-1018 Zydus Lifesciences Limited 180 TABLET in 1 BOTTLE (70771-1018-8) May 1, 2019
70771-1017 70771-1017 Zydus Lifesciences Limited — May 1, 2019
70771-1018 70771-1018 Zydus Lifesciences Limited — May 1, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.