Bosentan Tablets for Oral Suspension

Manufacturer: Zydus Lifesciences Limited
Effective date: 2026-02-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:06:20

Label at a glance#

Productbosentan

Active ingredientBOSENTAN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1908-8

Bosentan Tablets for Oral Suspension, 32 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Phenylketonurics: Contains Phenylalanine 2.08 mg per tablet for oral suspension.

56 Tablets (4 x 14 unit-dose)

Rx only

Zydus

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1989081	bosentan 32 MG Tablet for Oral Suspension	PSN	1
1989081	bosentan 32 MG Tablet for Oral Suspension	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BOSENTAN ANHYDROUS Pharmacologic Class Indexing	4	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d212b88c-a939-e294-be87-fb95301c9fbb	Product name	6	20251118

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70771-1908-7	bosentan	14 in 1 BLISTER PACK	TABLET, FOR SUSPENSION	14		1
70771-1908-8	bosentan	4 in 1 CARTON	TABLET, FOR SUSPENSION	4		1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

bosentan
BOSENTAN ANHYDROUS
ACESULFAME POTASSIUM
ASPARTAME
CROSCARMELLOSE SODIUM
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
STEARIC ACID
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1908	70771-1908-7, 70771-1908-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BOSENTAN	Q326023R30	ACTIM
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ASPARTAME	Z0H242BBR1	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	905HNO1SIH	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MANNITOL	3OWL53L36A	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STARCH, CORN	O8232NY3SJ	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213981-001	BOSENTAN	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB		2026-02-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213981-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A213981-001	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB	2026-02-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213981-001	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB	2026-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213981-001	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB	2026-02-17	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213981-001	BOSENTAN	32MG	TABLET, FOR SUSPENSION / ORAL	AB	2026-02-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A213981-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213981-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213981-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213981-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bosentan	BOSENTAN	Zydus Lifesciences Limited	b88cc559-93ae-42db-9c38-fb5e9c4802e6	2026-02-14		Exact identifier ndc (package): 70771-1908-7 ndc (package): 70771-1908-8 ndc (product): 70771-1908 ndc11 (package): 70771190808 ndc11 (package): 70771190807 spl id: 008fc213-caa0-4d52-9ee2-e3628c19b90b spl set id: b88cc559-93ae-42db-9c38-fb5e9c4802e6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.