Application 090364

Type: ANDA
Sponsor: WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;40MG	No	No
002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB		2011-07-05
A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB		2011-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090364-001	AB
A090364-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090364-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090364-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090364-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090364-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090364-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090364-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090364-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090364-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090364-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090364-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090364-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090364-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090364-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090364-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090364-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090364-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090364-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090364-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090364-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090364-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090364-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090364-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090364-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090364-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090364-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090364-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090364-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090364-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090364-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090364-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090364-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090364-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090364-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090364-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090364-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090364-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090364-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090364-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090364-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090364-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090364-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090364-002	AB	1	`74a2ff9319b5…`

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	0f253cac-67ac-4b03-b1a8-f2c345938dda	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	dc206611-5188-40a6-b025-61db41f68a5a	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	2542895b-c8f8-4f21-9e12-f5a7fe17f905	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	c695f95d-6064-4a22-84ba-c8e62477b3a7	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	318b3273-e8f7-416c-b371-10c56fa8e0fd	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	856a8cdc-57cc-4355-966d-986bbc5fa6e6	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5f7a4bd1-8083-46ca-95f2-e8c476b5367c	2026-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ff807933-7433-4f8c-9d09-02a57e51d0fc	2026-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	f16e04b5-57b9-49cc-811b-07d85ccb5d9f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	4e6bf47a-ee8a-4083-8cce-a6a25260d3fb	2026-02-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	ea774c36-e970-4d9c-9487-6cc57741fec5	2026-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	5813e6b6-f524-4fba-99ba-9f4e365bf523	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	c56a384c-b250-4a43-99ce-ddd88376c817	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	3b13554a-0f63-4238-8f55-a1400c847c9f	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	fa153720-b24c-60d0-e053-6294a90a97d5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	106c08c2-90eb-6bc0-e063-6294a90a5a23	2025-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	2b0e3752-c54e-4c50-9640-1a6fefa6dec5	2025-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	7a75935a-31af-4571-b7d9-8c297a635b57	2025-12-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	3ad66075-0875-4703-9d21-a424b5ab892a	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	c9693ad5-0fa6-4796-b20b-2021d589a132	2025-10-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Amlodipine Besylate and Benazepril Hydrochloride

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3761	Amlodipine and Benazepril Hydrochloride	Amlodipine and Benazepril Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
0591-3762	Amlodipine and Benazepril Hydrochloride	Amlodipine and Benazepril Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
50090-3404	Amlodipine and Benazepril Hydrochloride	Amlodipine and Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
63187-370	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Proficient Rx LP	ANDA	Current