BOSENTAN TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:18:14

Label at a glance#

ProductBosentan

Active ingredientBOSENTAN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1017-6

Bosentan tablets, 62.5 mg

60 tablets

Rx only

NDC 70771-1018-6

Bosentan tablets, 125 mg

60 tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
656659	bosentan 125 MG Oral Tablet	PSN	6
349253	bosentan 62.5 MG Oral Tablet	PSN	6
656659	bosentan 125 MG Oral Tablet	SCD	6
349253	bosentan 62.5 MG Oral Tablet	SCD	6
656659	bosentan (as bosentan hydrochloride) 125 MG Oral Tablet	SY	6
349253	bosentan (as bosentan hydrochloride) 62.5 MG Oral Tablet	SY	6

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1017-1	Bosentan	100 in 1 BOTTLE	TABLET	100	6
70771-1017-2	Bosentan	10 in 1 BLISTER PACK	TABLET	10	6
70771-1017-4	Bosentan	10 in 1 CARTON	TABLET	10	6
70771-1017-5	Bosentan	500 in 1 BOTTLE	TABLET	500	6
70771-1017-6	Bosentan	60 in 1 BOTTLE	TABLET	60	6
70771-1017-8	Bosentan	180 in 1 BOTTLE	TABLET	180	6
70771-1018-1	Bosentan	100 in 1 BOTTLE	TABLET	100	6
70771-1018-2	Bosentan	10 in 1 BLISTER PACK	TABLET	10	6
70771-1018-4	Bosentan	10 in 1 CARTON	TABLET	10	6
70771-1018-5	Bosentan	500 in 1 BOTTLE	TABLET	500	6
70771-1018-6	Bosentan	60 in 1 BOTTLE	TABLET	60	6
70771-1018-8	Bosentan	180 in 1 BOTTLE	TABLET	180	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1017	BOSENTAN TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 6 package rows	20241128_02892f47-0d59-4254-9ee7-d524278fdd79.zip
70771-1018	BOSENTAN TABLET [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 6 package rows	20241128_02892f47-0d59-4254-9ee7-d524278fdd79.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

Bosentan
BOSENTAN ANHYDROUS
ETHYLCELLULOSE, UNSPECIFIED
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GLYCERYL DIBEHENATE
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
TALC
TITANIUM DIOXIDE
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1017	70771-1017-6, 70771-1017-1, 70771-1017-8, 70771-1017-5, 70771-1017-2, 70771-1017-4
70771-1018	70771-1018-6, 70771-1018-1, 70771-1018-8, 70771-1018-5, 70771-1018-2, 70771-1018-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BOSENTAN	Q326023R30	ACTIM
ETHYLCELLULOSE, UNSPECIFIED	7Z8S9VYZ4B	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
BOSENTAN	Q326023R30	ACTIM
ETHYLCELLULOSE, UNSPECIFIED	7Z8S9VYZ4B	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POVIDONE	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STARCH, CORN	O8232NY3SJ	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207760-001	BOSENTAN	BOSENTAN	62.5MG	TABLET / ORAL	AB		2019-04-26
A207760-002	BOSENTAN	BOSENTAN	125MG	TABLET / ORAL	AB		2019-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207760-001	AB
A207760-002	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.

Product history page 1 of 3 · 88 observed 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	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207760-001	BOSENTAN	62.5MG	TABLET / ORAL	AB	2019-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207760-002	BOSENTAN	125MG	TABLET / ORAL	AB	2019-04-26	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A207760-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A207760-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A207760-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207760-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207760-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207760-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207760-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207760-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207760-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207760-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207760-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207760-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207760-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207760-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207760-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207760-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207760-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207760-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207760-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207760-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207760-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207760-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207760-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207760-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207760-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207760-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207760-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207760-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207760-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207760-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207760-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207760-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207760-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207760-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207760-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207760-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207760-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207760-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207760-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207760-002	AB	1	`4b0b4de00fa7…`

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	02892f47-0d59-4254-9ee7-d524278fdd79	2024-11-25		Exact identifier ndc (package): 70771-1018-5 ndc (package): 70771-1018-1 ndc (package): 70771-1017-1 ndc (package): 70771-1017-2 ndc (package): 70771-1018-6 ndc (package): 70771-1018-8 ndc (package): 70771-1017-5 ndc (package): 70771-1018-2 ndc (package): 70771-1017-4 ndc (package): 70771-1017-8 ndc (package): 70771-1018-4 ndc (package): 70771-1017-6 ndc (product): 70771-1017 ndc (product): 70771-1018 ndc11 (package): 70771101804 ndc11 (package): 70771101701 ndc11 (package): 70771101801 ndc11 (package): 70771101706 ndc11 (package): 70771101802 ndc11 (package): 70771101808 ndc11 (package): 70771101705 ndc11 (package): 70771101708 ndc11 (package): 70771101702 ndc11 (package): 70771101805 ndc11 (package): 70771101704 ndc11 (package): 70771101806 spl id: 33935d05-c8ff-4d9e-91bf-fac9072d25fd spl set id: 02892f47-0d59-4254-9ee7-d524278fdd79

Reported adverse events (FAERS/openFDA)#

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