Benazepril Hydrochloride

Product NDC: 54458-862
Requested package NDC: 54458-862-16
11-digit product format: 544580862
Labeler code: 54458
Product ID: 54458-862_78d6f59d-2648-4d4d-977e-3df83d662e04
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benazepril Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: International Laboratories, LLC
Application: ANDA076118
Marketing category: ANDA
Marketing start: 2014-02-01
Marketing end: 0000-00-00
Substance: BENAZEPRIL HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54458-862	54458-862-16	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	TE codes	Approval date
A076118-001	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11
A076118-002	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11
A076118-003	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11
A076118-004	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A076118-001	AB
A076118-002	AB
A076118-003	AB
A076118-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076118-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076118-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076118-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076118-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076118-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076118-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076118-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076118-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076118-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076118-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076118-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076118-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076118-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076118-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076118-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076118-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076118-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076118-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076118-004	AB	1	`d8e5a09893c0…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54458-862-10	2023-01-30	C162847	48780-1	f386c649-9aef-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
54458-862-16	2023-01-30	C162847	48780-1	f386c649-9aef-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54458-862-10	Benazepril Hydrochloride	30 in 1 BLISTER PACK	TABLET, COATED	30		10
54458-862-16	Benazepril Hydrochloride	30 in 1 BOTTLE	TABLET, COATED	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54458-862-10	EA - Each	54458-862	4240942e-0099-4644-aaa0-e409e4523fe9	1	2016-04-04
54458-862-16	EA - Each	54458-862	9500a54d-55ea-4730-bf31-1222bed8caa1	1	2017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54458-862	BENAZEPRIL HYDROCHLORIDE TABLET, COATED [INTERNATIONAL LABORATORIES, LLC]	10	Legacy NDC, 2 package rows	20191219_b454cc1f-58ab-4b21-ae02-e06ec626b9d6.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	REMEDYREPACK INC.	afd616b9-0c75-48be-862d-5ac18364fd9d	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	01a3c9f6-41aa-47a7-8c56-5462c6b54416	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals, Inc.	032ea0f7-3304-4778-b3a6-6125ea7537ab	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	7aac6a2f-85fb-4c7a-b424-9c253186dffe	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	3631d1dc-45e1-0588-e054-00144ff88e88	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	708110e5-fa45-44e0-9011-261f4490ea45	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	471cd30a-401a-c8f9-e063-6294a90a4787	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	6c24bb4c-42d2-483a-b33f-95182b32b93d	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	8f46e2c9-9b3b-48d0-a307-9069e3879959	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Golden State Medical Supply, Inc.	cb93e793-fe4f-452c-e053-2995a90a7333	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1a7b373a-9b74-4b9d-93fb-081614222e30	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	355811f0-2885-0d49-e054-00144ff8d46c	2025-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	55c99902-3d4d-05e9-e054-00144ff8d46c	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4d5a8b50-dd2f-4329-9e28-93608e8fe8da	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	DIRECT RX	a7e4e43a-7abc-e2a5-e053-2995a90ab5f4	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	08bc0034-3b33-47d8-aec2-b36535ac85a2	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	0653322d-70c6-45f7-a9d1-41efee1d7387	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	7274fdaf-1247-2b2f-e053-2991aa0ad3f6	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	700c828c-86c6-1857-e053-2a91aa0ae314	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9535ec77-2d50-4817-e053-2995a90a007e	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N1SN99T69T	BENAZEPRIL HYDROCHLORIDE	86541-74-4	BENAZEPRIL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
898690	benazepril HCl 20 MG Oral Tablet	PSN	b454cc1f-58ab-4b21-ae02-e06ec626b9d6	10
898719	benazepril HCl 40 MG Oral Tablet	PSN	b454cc1f-58ab-4b21-ae02-e06ec626b9d6	10
898690	benazepril hydrochloride 20 MG Oral Tablet	SCD	b454cc1f-58ab-4b21-ae02-e06ec626b9d6	10
898719	benazepril hydrochloride 40 MG Oral Tablet	SCD	b454cc1f-58ab-4b21-ae02-e06ec626b9d6	10
898690	BZP hydrochloride 20 MG Oral Tablet	SY	b454cc1f-58ab-4b21-ae02-e06ec626b9d6	10
898719	BZP hydrochloride 40 MG Oral Tablet	SY	b454cc1f-58ab-4b21-ae02-e06ec626b9d6	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54458-862-16	54458086216	30 TABLET, COATED in 1 BOTTLE (54458-862-16)	2017-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benazepril Hydrochloride	International Laboratories, LLC \| Zhejiang Huahai Pharmaceutical Co., Ltd.	2019-12-18	HUMAN PRESCRIPTION DRUG LABEL	10