amlodipine besylate and benazepril hydrochloride

Product NDC: 0615-1397
11-digit product format: 006151397
Labeler code: 0615
Product ID: 0615-1397_d9910f83-8c88-4269-a518-60d97c2d4ff2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate and benazepril hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: NDA020364
Marketing category: NDA
Marketing start: 1995-03-03
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: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-1397		D	Discontinued by firm		2026-08-07
excluded package	package	0615-1397	0615-1397-39	D	Discontinued by firm		2026-08-07

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 · 30 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	0615-1397-39	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	0615-1397-39	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	0615-1397-39	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	0615-1397-39	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	0615-1397-39	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	0615-1397-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-1397-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-1397-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-1397-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-1397-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-1397-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-1397-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-1397-39	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…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-1397-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-1397-39	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

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	RLD / RS	Approval date
N020364-002	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-003	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;10MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-004	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;20MG	CAPSULE / ORAL	RLD	1995-03-03
N020364-005	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;20MG	CAPSULE / ORAL	RLD	2002-06-20
N020364-006	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 10MG BASE;40MG	CAPSULE / ORAL	RLD	2006-04-11
N020364-007	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	EQ 5MG BASE;40MG	CAPSULE / ORAL	RLD	2006-04-11

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-006	LOTREL	EQ 10MG BASE;40MG	CAPSULE / ORAL	AB	RLD, RS	2006-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-007	LOTREL	EQ 5MG BASE;40MG	CAPSULE / ORAL	AB	RLD	2006-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-002	LOTREL	EQ 2.5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-003	LOTREL	EQ 5MG BASE;10MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-004	LOTREL	EQ 5MG BASE;20MG	CAPSULE / ORAL	AB	RLD	1995-03-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-005	LOTREL	EQ 10MG BASE;20MG	CAPSULE / ORAL	AB	RLD	2002-06-20	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 240 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	N020364-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020364-007	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020364-007	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020364-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020364-007	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020364-007	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020364-007	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-006	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020364-007	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020364-005	AB	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-1397-39	2021-02-26	C162847	48780-1	97449f38-c9d4-f6ea-e053-dbdaa90aa703	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 . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995
0615-1397-39	2019-11-13	C162847	48780-1	97449f38-c9d4-f6ea-e053-dbdaa90aa703	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 . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	12

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
Lotrel	AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE	Novartis Pharmaceuticals Corporation	94ae6054-b7ae-4212-a567-4f803af8f2c7	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020364 application number: NDA020364

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	NCS HealthCare of KY, Inc dba Vangard Labs	2012-05-09	HUMAN PRESCRIPTION DRUG LABEL	12