Amlodipine besylate and Benazepril hydrochloride

Product NDC: 69097-145
11-digit product format: 690970145
Labeler code: 69097
Product ID: 69097-145_fe4e181b-b969-4ca9-91a4-df6d8957c759
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amlodipine besylate and Benazepril hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA077215
Marketing category: ANDA
Marketing start: 2018-12-07
Marketing end: 0000-00-00
Substance: AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength: 5 mg/1; mg/1
Pharmacologic classes: Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69097-145		D	Discontinued by firm	2026-10-05
excluded package	package	69097-145	69097-145-02	D	Discontinued by firm	2026-10-05
excluded package	package	69097-145	69097-145-06	D	Discontinued by firm	2026-10-05
excluded package	package	69097-145	69097-145-12	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 84 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69097-145-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69097-145-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69097-145-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69097-145-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69097-145-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69097-145-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69097-145-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69097-145-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69097-145-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69097-145-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69097-145-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69097-145-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69097-145-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69097-145-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69097-145-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69097-145-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69097-145-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69097-145-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69097-145-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69097-145-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69097-145-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69097-145-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69097-145-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69097-145-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69097-145-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69097-145-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69097-145-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69097-145-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69097-145-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69097-145-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69097-145-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69097-145-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69097-145-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69097-145-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69097-145-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69097-145-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69097-145-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69097-145-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69097-145-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69097-145-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69097-145-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69097-145-06	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69097-145-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69097-145-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69097-145-06	`1332a3947898…`	`d4bfe170f9cd…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07
A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07
A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07
A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077215-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2018-12-07	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
69097-145-02	2025-12-15	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval:1995
69097-145-06	2025-12-15	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval:1995
69097-145-12	2025-12-15	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval:1995
69097-145-02	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval:1995
69097-145-06	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval:1995
69097-145-12	2020-01-31	These highlights do not include all the information needed to use AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsules, for oral use Initial U.S. Approval:1995

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-145	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [CIPLA USA INC.]	4	Legacy NDC	20181220_fc5b81e5-aa88-4d1e-8bca-88b2bef0edd1.zip

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
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	Exact identifier application applno (ANDA): 077215 application number: ANDA077215

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
N1SN99T69T	BENAZEPRIL HYDROCHLORIDE	86541-74-4	BENAZEPRIL HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amlodipine besylate and Benazepril hydrochloride	Cipla USA Inc. \| Cipla Ltd.- Goa	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	4