Benazepril Hydrochloride

Product NDC: 63187-393
11-digit product format: 631870393
Labeler code: 63187
Product ID: 63187-393_cac335b0-2fc0-420f-b52a-a7216e940192
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benazepril Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076118
Marketing category: ANDA
Marketing start: 2014-01-01
Substance: BENAZEPRIL HYDROCHLORIDE
Active strength: 20 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: 2027-12-31
Current FDA listing: Yes

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	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 · 172 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
2026-09-14 22:38:34	2026-08	A076118-001	BENAZEPRIL HYDROCHLORIDE	5MG	TABLET / ORAL	AB	2004-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076118-002	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2004-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076118-003	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB	2004-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076118-004	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	2004-02-11	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076118-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076118-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076118-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076118-004	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Benazepril Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENAZEPRIL HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N1SN99T69T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
898690	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
be41d21c-4747-47bb-b4b7-bbfabcd7a9b1	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63187-393-30	Benazepril Hydrochloride	30 in 1 BOTTLE	TABLET, COATED	30		4
63187-393-90	Benazepril Hydrochloride	90 in 1 BOTTLE	TABLET, COATED	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-393-30	EA - Each	63187-393	2b18a160-5acc-4445-9615-27bd29c9b8e2	1	2020-01-03
63187-393-90	EA - Each	63187-393	4992c6df-1639-4fae-a72f-94029c645fe9	1	2016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-393	BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 2 package rows	20240711_be41d21c-4747-47bb-b4b7-bbfabcd7a9b1.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 2 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	NuCare Pharmaceuticals, Inc.	53fea330-cc4a-3b7e-e054-00144ff88e88	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Proficient Rx LP	be41d21c-4747-47bb-b4b7-bbfabcd7a9b1	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118 ndc (product): 63187-393
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Solco healthcare U.S., LLC	bb91223e-ffa5-4a3a-b191-fe121250c20c	2024-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	99755c59-18b9-ab7b-e053-2a95a90a4155	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9987a842-07a5-635e-e053-2995a90afa32	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Proficient Rx LP	ebdf5144-752d-456f-b46d-19cbba0bc3d7	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	b0d3122a-5332-4af6-98d8-520ed70ace62	2023-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076118 application number: ANDA076118
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Proficient Rx LP	313225d7-f947-40b3-96d7-289aad300a4a	2023-08-01	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	be41d21c-4747-47bb-b4b7-bbfabcd7a9b1	4
898690	benazepril hydrochloride 20 MG Oral Tablet	SCD	be41d21c-4747-47bb-b4b7-bbfabcd7a9b1	4
898690	BZP hydrochloride 20 MG Oral Tablet	SY	be41d21c-4747-47bb-b4b7-bbfabcd7a9b1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-393-30	63187039330	30 TABLET, COATED in 1 BOTTLE (63187-393-30)	2016-09-01	0000-00-00	No	No	Current
63187-393-60	63187039360	60 TABLET, COATED in 1 BOTTLE (63187-393-60)	2016-09-01	0000-00-00	No	No	Current
63187-393-90	63187039390	90 TABLET, COATED in 1 BOTTLE (63187-393-90)	2016-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benazepril Hydrochloride Tablets, USP, film coated for oral use	Proficient Rx LP	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	4