Benazepril Hydrochloride

Product NDC
71335-1086
Requested package NDC
71335-1086-2
11-digit product format
713351086
Labeler code
71335
Product ID
71335-1086_fc9d1bd9-f945-7c61-e053-6294a90a3117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
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
2026-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-108671335-1086-2DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 HYDROCHLORIDE20 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b02c240-4393-48ed-a385-561ced7b7abfAvailable 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
71335-1086-1Benazepril Hydrochloride30 in 1 BOTTLETABLET30101
71335-1086-2Benazepril Hydrochloride60 in 1 BOTTLETABLET60101
71335-1086-3Benazepril Hydrochloride100 in 1 BOTTLETABLET100101
71335-1086-4Benazepril Hydrochloride90 in 1 BOTTLETABLET90101
71335-1086-5Benazepril Hydrochloride14 in 1 BOTTLETABLET14101
71335-1086-6Benazepril Hydrochloride10 in 1 BOTTLETABLET10101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1086BENAZEPRIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 6 package rows20230603_2b02c240-4393-48ed-a385-561ced7b7abf.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
ndc (package): 71335-1086-2
ndc (product): 71335-1086
ndc11 (package): 71335108602
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN2b02c240-4393-48ed-a385-561ced7b7abf101
898690benazepril hydrochloride 20 MG Oral TabletSCD2b02c240-4393-48ed-a385-561ced7b7abf101
898690BZP hydrochloride 20 MG Oral TabletSY2b02c240-4393-48ed-a385-561ced7b7abf101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1086-27133510860260 TABLET in 1 BOTTLE (71335-1086-2) 60 tablet2022-05-040000-00-00NoNoCurrent