Benazepril Hydrochloride

Product NDC: 51655-388
11-digit product format: 516550388
Labeler code: 51655
Product ID: 51655-388_48fed634-c2b9-ba9e-e063-6394a90aab7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benazepril Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA078212
Marketing category: ANDA
Marketing start: 2023-05-19
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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078212-001	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22
A078212-002	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22
A078212-003	BENAZEPRIL HYDROCHLORIDE	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078212-001	AB
A078212-002	AB
A078212-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078212-002	BENAZEPRIL HYDROCHLORIDE	20MG	TABLET / ORAL	AB		2008-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078212-003	BENAZEPRIL HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RS	2008-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078212-001	BENAZEPRIL HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-05-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078212-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078212-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078212-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078212-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078212-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078212-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078212-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078212-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078212-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078212-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078212-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078212-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078212-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078212-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078212-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078212-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078212-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078212-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078212-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078212-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078212-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078212-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078212-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078212-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078212-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078212-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078212-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078212-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078212-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078212-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078212-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078212-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078212-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078212-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078212-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078212-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078212-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078212-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078212-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078212-001	AB	1	`1e350fbaab3a…`

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
fc4cd253-13ee-9424-e053-6394a90a35a8	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
51655-388-52	Benazepril Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-388	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20230701_fc4cd253-13ee-9424-e053-6394a90a35a8.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Bryant Ranch Prepack	58977ec4-36ea-4d81-a8f0-7298425cbc84	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Aurobindo Pharma Limited	09e383a8-e912-4cf7-8fb3-05545af80dd0	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Aurobindo Pharma Limited	67c64de1-5579-46e4-82ee-c9bbee708e02	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	f7f9dc46-a947-7ae3-e053-6394a90a1192	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	fc4cd253-13ee-9424-e053-6394a90a35a8	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212 ndc (product): 51655-388
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Northwind Health Company, LLC	f32d01db-655b-f3d0-e053-2a95a90a04f6	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	fade97e1-8400-4214-b750-e7656cae7a0f	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	91a3d0f7-d2df-4230-ad9e-b32f7312d337	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9016634a-1bdd-700d-e053-2995a90a8f27	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	800f2a14-98b9-3499-e053-2991aa0a197d	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	e0d5362b-f5da-4838-ae91-22f40fcca245	2023-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	A-S Medication Solutions	c5090372-41bf-4677-b198-97fd55a0cb87	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212
Benazepril Hydrochloride	BENAZEPRIL HYDROCHLORIDE	Proficient Rx LP	92a26516-3d84-4d7a-a770-523926507887	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078212 application number: ANDA078212

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	fc4cd253-13ee-9424-e053-6394a90a35a8	2
898690	benazepril hydrochloride 20 MG Oral Tablet	SCD	fc4cd253-13ee-9424-e053-6394a90a35a8	2
898690	BZP hydrochloride 20 MG Oral Tablet	SY	fc4cd253-13ee-9424-e053-6394a90a35a8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-388-52	51655038852	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-388-52)	2023-05-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benazepril Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2