AMBRISENTAN Tablets

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 21:18:06

Label at a glance#

ProductAmbrisentan

Active ingredientAMBRISENTAN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1363-3

Ambrisentan Tablets, 5 mg

30 Tablets

Rx only

NDC 70771-1364-3

Ambrisentan Tablets, 10 mg

30 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
722116	ambrisentan 10 MG Oral Tablet	PSN	10
722122	ambrisentan 5 MG Oral Tablet	PSN	10
722116	ambrisentan 10 MG Oral Tablet	SCD	10
722122	ambrisentan 5 MG Oral Tablet	SCD	10

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
AMBRISENTAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
d7db2b61-402f-f2c9-6e9c-10d81037d0ba	Product name	3	20230126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1363-1	Ambrisentan	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
70771-1363-3	Ambrisentan	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
70771-1363-7	Ambrisentan	1 in 1 CARTON	TABLET, FILM COATED	1	10
70771-1363-7	Ambrisentan	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	10
70771-1363-8	Ambrisentan	3 in 1 CARTON	TABLET, FILM COATED	3	10
70771-1363-8	Ambrisentan	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	10
70771-1363-9	Ambrisentan	90 in 1 BOTTLE	TABLET, FILM COATED	90	10
70771-1364-1	Ambrisentan	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
70771-1364-3	Ambrisentan	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
70771-1364-7	Ambrisentan	1 in 1 CARTON	TABLET, FILM COATED	1	10
70771-1364-7	Ambrisentan	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	10
70771-1364-8	Ambrisentan	3 in 1 CARTON	TABLET, FILM COATED	3	10
70771-1364-8	Ambrisentan	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	10
70771-1364-9	Ambrisentan	90 in 1 BOTTLE	TABLET, FILM COATED	90	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1363	AMBRISENTAN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	10	Current NDC, Legacy NDC, 7 package rows	20241127_0e3e3320-27ac-404f-9f01-3d82696e768a.zip
70771-1364	AMBRISENTAN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	10	Current NDC, Legacy NDC, 7 package rows	20241127_0e3e3320-27ac-404f-9f01-3d82696e768a.zip

Products#

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

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

Ambrisentan
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
TALC
TITANIUM DIOXIDE
FD&C RED NO. 40
ALUMINUM OXIDE
POLYVINYL ALCOHOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1363	70771-1363-3, 70771-1363-9, 70771-1363-1, 70771-1363-8, 70771-1363-7
70771-1364	70771-1364-3, 70771-1364-9, 70771-1364-1, 70771-1364-8, 70771-1364-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMBRISENTAN	HW6NV07QEC	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
AMBRISENTAN	HW6NV07QEC	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210058-001	AMBRISENTAN	AMBRISENTAN	5MG	TABLET / ORAL	AB		2019-03-28
A210058-002	AMBRISENTAN	AMBRISENTAN	10MG	TABLET / ORAL	AB		2019-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210058-001	AB
A210058-002	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	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210058-001	AMBRISENTAN	5MG	TABLET / ORAL	AB	2019-03-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210058-002	AMBRISENTAN	10MG	TABLET / ORAL	AB	2019-03-28	`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	A210058-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210058-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210058-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210058-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210058-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210058-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210058-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210058-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210058-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210058-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210058-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210058-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210058-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210058-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210058-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210058-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210058-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210058-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210058-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210058-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210058-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210058-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210058-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210058-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210058-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210058-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210058-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210058-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210058-002	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
Ambrisentan	AMBRISENTAN	Zydus Lifesciences Limited	0e3e3320-27ac-404f-9f01-3d82696e768a	2024-11-25		Exact identifier ndc (package): 70771-1364-7 ndc (package): 70771-1363-9 ndc (package): 70771-1363-8 ndc (package): 70771-1364-1 ndc (package): 70771-1364-3 ndc (package): 70771-1364-9 ndc (package): 70771-1363-1 ndc (package): 70771-1363-3 ndc (package): 70771-1363-7 ndc (package): 70771-1364-8 ndc (product): 70771-1364 ndc (product): 70771-1363 ndc11 (package): 70771136407 ndc11 (package): 70771136301 ndc11 (package): 70771136408 ndc11 (package): 70771136307 ndc11 (package): 70771136308 ndc11 (package): 70771136403 ndc11 (package): 70771136401 ndc11 (package): 70771136303 ndc11 (package): 70771136309 ndc11 (package): 70771136409 spl id: 14a85c38-61bf-4621-8e3a-34ab57a15758 spl set id: 0e3e3320-27ac-404f-9f01-3d82696e768a

Reported adverse events (FAERS/openFDA)#

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