Amlodipine besylate and benazepril hydrochloride

Product NDC: 49884-930
11-digit product format: 498840930
Labeler code: 49884
Product ID: 49884-930_a7dff6fb-1626-4f44-8ca1-34191eaaae84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate and benazepril hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Pharmaceutical Inc.
Application: ANDA078381
Marketing category: ANDA
Marketing start: 2011-01-03
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: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49884-930		D	Discontinued by firm	2026-10-12
excluded package	package	49884-930	49884-930-01	D	Discontinued by firm	2026-10-12
excluded package	package	49884-930	49884-930-05	D	Discontinued by firm	2026-10-12

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 1 · 46 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-930-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49884-930-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-930-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49884-930-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-930-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49884-930-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-930-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49884-930-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-930-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49884-930-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-930-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49884-930-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-930-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49884-930-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-930-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49884-930-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-930-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49884-930-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-930-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49884-930-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-930-05	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49884-930-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-930-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49884-930-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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

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	Approval date
A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29
A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29
A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29
A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29
A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29
A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29

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 · 258 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	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-005	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078381-006	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	2010-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-001	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-002	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-003	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078381-004	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	2010-07-29	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A078381-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078381-006	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A078381-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078381-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078381-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078381-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078381-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078381-006	AB	1	`ea99ee380514…`

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
49884-930-01	2025-02-05	These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
49884-930-05	2025-02-05	These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
49884-930-01	2020-01-31	These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
49884-930-05	2020-01-31	These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-930-01	EA - Each	49884-930	2c9d9c16-bc09-4aa5-8f78-98fbfdd5f31f	1	2012-07-24
49884-930-05	EA - Each	49884-930	d03b9eec-61ed-4bf5-982f-b32777c9da81	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE) CAPSULE [BRYANT RANCH PREPACK]	1001
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [PAR PHARMACEUTICAL INC.]	9

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	Par Pharmaceutical Inc.	2016-08-19	HUMAN PRESCRIPTION DRUG LABEL	10
Amlodipine besylate and benazepril hydrochloride	Bryant Ranch Prepack	2014-05-08	HUMAN PRESCRIPTION DRUG LABEL	1001