Benazepril Hydrochloride

Product NDC
65162-751
11-digit product format
651620751
Labeler code
65162
Product ID
65162-751_1897ce48-56e1-415f-9db3-224c48b3063e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
5 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
2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076820-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03
A076820-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-03
A076820-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-03
A076820-004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076820-001AB
A076820-002AB
A076820-003AB
A076820-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-03caaa826d4ba7…
2026-08-18 06:07:402026-07A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2006-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2006-02-03d8e5a09893c0…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076820-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076820-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076820-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076820-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076820-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076820-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076820-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076820-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076820-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076820-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076820-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076820-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076820-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076820-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076820-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076820-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076820-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076820-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076820-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N1SN99T69TInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
898687Internal RxNorm lookup
898690Internal RxNorm lookup
898719Internal RxNorm lookup
898723Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a216253b-27cb-42ef-b5a8-67fb05aafb88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-751-03Benazepril Hydrochloride30 in 1 BOTTLETABLET3020
65162-751-10Benazepril Hydrochloride100 in 1 BOTTLETABLET10020
65162-751-50Benazepril Hydrochloride500 in 1 BOTTLETABLET50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-751-10EA - Each65162-75145c97589-8a1b-4bc6-9d77-eda20f5a71a612012-07-24
65162-751-50EA - Each65162-751e421c45d-f45e-4081-9683-1d8b76fee0e312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]11
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
CrospovidoneINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Magnesium StearateINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Starch, CornINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
TalcINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-751BENAZEPRIL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 3 package rows20241025_a216253b-27cb-42ef-b5a8-67fb05aafb88.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDECardinal Health 107, LLCf265e6dd-f47e-4511-9468-282184bcd1b12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf99d3d0d-cee8-b260-e053-6294a90ac3cb2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAvPAKf004d7e2-fc45-8a37-e548-eeaaa327f9b52025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackcd1a7c8f-cc61-4ee4-a259-0b3329cced3e2023-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack2b02c240-4393-48ed-a385-561ced7b7abf2023-05-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack449e89a3-7bef-44eb-8d73-c77ece611cce2023-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEProficient Rx LP9593989f-3129-48ad-9b30-f0b52fb3e91e2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAmneal Pharmaceuticals LLCa216253b-27cb-42ef-b5a8-67fb05aafb882019-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076820
application number: ANDA076820
ndc (product): 65162-751

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898690benazepril HCl 20 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898719benazepril HCl 40 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723benazepril HCl 5 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898687benazepril hydrochloride 10 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898690benazepril hydrochloride 20 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898719benazepril hydrochloride 40 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723benazepril hydrochloride 5 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723benazepril HCl 5 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898687BZP hydrochloride 10 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898690BZP hydrochloride 20 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898719BZP hydrochloride 40 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723BZP hydrochloride 5 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-751-036516207510330 TABLET in 1 BOTTLE (65162-751-03) 30 tablet2010-02-020000-00-00NoNoCurrent
65162-751-1065162075110100 TABLET in 1 BOTTLE (65162-751-10) 100 tablet2010-02-020000-00-00NoNoCurrent
65162-751-5065162075150500 TABLET in 1 BOTTLE (65162-751-50) 500 tablet2010-02-020000-00-00NoNoCurrent