Benazepril Hydrochloride

Product NDC: 65862-116
Requested package NDC: 65862-116-01
11-digit product format: 658620116
Labeler code: 65862
Product ID: 65862-116_6c4a4520-30af-4362-a40d-124510bd9ed2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benazepril Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078212
Marketing category: ANDA
Marketing start: 2008-05-22
Marketing end: 0000-00-00
Substance: BENAZEPRIL HYDROCHLORIDE
Active strength: 10 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: 2023-12-31
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	65862-116	65862-116-01	D	Discontinued by firm		2026-08-17

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…`

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
65862-116-01	Benazepril Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		26
65862-116-90	Benazepril Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-116-01	EA - Each	65862-116	159b838b-4a29-464d-82fe-d5ff8bff31fd	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENAZEPRIL HYDROCHLORIDE	ACTIVE INGREDIENT	N1SN99T69T	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
BENAZEPRILAT	ACTIVE MOIETY	JRM708L703	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-116	BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	25	Legacy NDC, 2 package rows	20240509_09e383a8-e912-4cf7-8fb3-05545af80dd0.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 ndc (package): 65862-116-01 ndc (product): 65862-116 ndc11 (package): 65862011601
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
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
898687	benazepril HCl 10 MG Oral Tablet	PSN	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898690	benazepril HCl 20 MG Oral Tablet	PSN	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898719	benazepril HCl 40 MG Oral Tablet	PSN	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898687	benazepril hydrochloride 10 MG Oral Tablet	SCD	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898690	benazepril hydrochloride 20 MG Oral Tablet	SCD	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898719	benazepril hydrochloride 40 MG Oral Tablet	SCD	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898687	BZP hydrochloride 10 MG Oral Tablet	SY	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898690	BZP hydrochloride 20 MG Oral Tablet	SY	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898719	BZP hydrochloride 40 MG Oral Tablet	SY	09e383a8-e912-4cf7-8fb3-05545af80dd0	26
898687	benazepril HCl 10 MG Oral Tablet	PSN	fade97e1-8400-4214-b750-e7656cae7a0f	8
898687	benazepril hydrochloride 10 MG Oral Tablet	SCD	fade97e1-8400-4214-b750-e7656cae7a0f	8
898687	BZP hydrochloride 10 MG Oral Tablet	SY	fade97e1-8400-4214-b750-e7656cae7a0f	8
898687	benazepril HCl 10 MG Oral Tablet	PSN	f7f9dc46-a947-7ae3-e053-6394a90a1192	2
898687	benazepril hydrochloride 10 MG Oral Tablet	SCD	f7f9dc46-a947-7ae3-e053-6394a90a1192	2
898687	BZP hydrochloride 10 MG Oral Tablet	SY	f7f9dc46-a947-7ae3-e053-6394a90a1192	2
898687	benazepril HCl 10 MG Oral Tablet	PSN	91a3d0f7-d2df-4230-ad9e-b32f7312d337	1
898687	benazepril HCl 10 MG Oral Tablet	PSN	0339ccda-e837-5726-e063-6294a90a6650	1
898687	benazepril hydrochloride 10 MG Oral Tablet	SCD	0339ccda-e837-5726-e063-6294a90a6650	1
898687	benazepril hydrochloride 10 MG Oral Tablet	SCD	91a3d0f7-d2df-4230-ad9e-b32f7312d337	1
898687	BZP hydrochloride 10 MG Oral Tablet	SY	0339ccda-e837-5726-e063-6294a90a6650	1
898687	BZP hydrochloride 10 MG Oral Tablet	SY	91a3d0f7-d2df-4230-ad9e-b32f7312d337	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-116-01	65862011601	100 TABLET, FILM COATED in 1 BOTTLE (65862-116-01)	2008-05-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benazepril Hydrochloride	Aurobindo Pharma Limited	2026-03-13	Human Prescription Drug Label	26
Benazepril Hydrochloride	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Benazepril Hydrochloride	A-S Medication Solutions	2025-06-12	Human Prescription Drug Label	8
Benazepril Hydrochloride	Preferred Pharmaceuticals Inc.	2025-05-19	HUMAN PRESCRIPTION DRUG LABEL	1
Benazepril Hydrochloride	REMEDYREPACK INC.	2024-03-12	HUMAN PRESCRIPTION DRUG LABEL	4
Benazepril Hydrochloride	NuCare Pharmaceuticals,Inc.	2023-08-18	HUMAN PRESCRIPTION DRUG LABEL	1