Application 078466

Type: ANDA
Sponsor: LUPIN PHARMS

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 2.5MG BASE;10MG	No	No
002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;10MG	No	No
003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;20MG	No	No
004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;20MG	No	No
005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;40MG	No	No
006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;40MG	No	No
007	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE; ORAL	10MG; 40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB		2010-02-05
A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB		2010-02-05
A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB		2010-02-05
A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB		2010-02-05
A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB		2011-07-05
A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RS	2011-07-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A078466-001	AB
A078466-002	AB
A078466-003	AB
A078466-004	AB
A078466-005	AB
A078466-006	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 7 · 246 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
2026-02-19 14:30 UTC	2026-02	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-006	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	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-005	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	A078466-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	2011-07-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-006	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	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-005	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	A078466-006	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	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-005	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	A078466-006	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	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-005	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	A078466-006	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	A078466-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	2010-02-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078466-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078466-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078466-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078466-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078466-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078466-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078466-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078466-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078466-004	AB	1	`2680178bc6a6…`

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 · 19 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	A-S Medication Solutions	c695f95d-6064-4a22-84ba-c8e62477b3a7	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 50090-5357
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 71335-1946
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 70518-2566
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 50090-6185
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 50090-5389
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 50090-5404
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	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Lupin Pharmaceuticals, Inc.	968c611b-43a7-40f0-9ed3-aa67ee88364b	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 68180-755 ndc (product): 68180-473 ndc (product): 68180-756 ndc (product): 68180-459 ndc (product): 68180-758 ndc (product): 68180-759 ndc (product): 68180-472 ndc (product): 68180-760 ndc (product): 68180-757 ndc (product): 68180-463
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	dc206611-5188-40a6-b025-61db41f68a5a	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	0f253cac-67ac-4b03-b1a8-f2c345938dda	2025-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	d058e426-8786-4fd3-a771-992e4558c135	2025-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	7c75fa72-9b0f-44bf-a745-dfa647ed1e78	2025-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466
Amlodipine Besylate and Benazepril Hydrochloride	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	BluePoint Laboratories	df8e23c8-6c8f-4293-8a37-5ad3d48dba94	2023-05-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078466 application number: ANDA078466 ndc (product): 68001-130 ndc (product): 68001-131 ndc (product): 68001-134 ndc (product): 68001-135 ndc (product): 68001-133 ndc (product): 68001-132

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 69 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-571	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-571	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-5357	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5389	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5404	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-6185	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	A-S Medication Solutions	ANDA	Current
68001-130	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-130	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-130	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-130	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-131	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-131	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-131	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-131	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-132	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-132	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-132	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-132	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-133	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-133	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-133	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-133	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-134	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-134	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-134	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-134	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-135	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-135	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-135	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-135	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	BluePoint Laboratories	ANDA	Current
68151-1364	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Carilion Materials Management	ANDA	Current
68180-459	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-459	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-459	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-459	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-463	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-463	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-463	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-463	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-472	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-472	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-472	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-472	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-473	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-473	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-473	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-473	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-755	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-755	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-755	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-755	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-756	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-756	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-756	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-756	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-757	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-757	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-758	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-759	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-759	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-760	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-760	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-2566	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2566	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3030	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-3303	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70934-560	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-637	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
71335-1946	Amlodipine Besylate and Benazepril Hydrochloride	Amlodipine Besylate and Benazepril Hydrochloride	Bryant Ranch Prepack	ANDA	Current