Benazepril Hydrochloride

Product NDC
71335-0854
11-digit product format
713350854
Labeler code
71335
Product ID
71335-0854_a518664a-2636-475f-824b-81cc1e710c78
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
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
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 HYDROCHLORIDE10 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
898687Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd1a7c8f-cc61-4ee4-a259-0b3329cced3eAvailable 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
71335-0854-1Benazepril Hydrochloride30 in 1 BOTTLETABLET3011
71335-0854-2Benazepril Hydrochloride60 in 1 BOTTLETABLET6011
71335-0854-3Benazepril Hydrochloride100 in 1 BOTTLETABLET10011
71335-0854-4Benazepril Hydrochloride90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0854-1EA - Each71335-08542834a3f4-058c-4602-b31b-22c7877d6cad12020-09-14
71335-0854-4EA - Each71335-0854b248f144-79de-4ac5-a391-aa02b69db39312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0854BENAZEPRIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 4 package rows20231128_cd1a7c8f-cc61-4ee4-a259-0b3329cced3e.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
ndc (product): 71335-0854
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNcd1a7c8f-cc61-4ee4-a259-0b3329cced3e11
898687benazepril hydrochloride 10 MG Oral TabletSCDcd1a7c8f-cc61-4ee4-a259-0b3329cced3e11
898687BZP hydrochloride 10 MG Oral TabletSYcd1a7c8f-cc61-4ee4-a259-0b3329cced3e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0854-17133508540130 TABLET in 1 BOTTLE (71335-0854-1) 30 tablet2018-08-170000-00-00NoNoCurrent
71335-0854-27133508540260 TABLET in 1 BOTTLE (71335-0854-2) 60 tablet2022-03-090000-00-00NoNoCurrent
71335-0854-371335085403100 TABLET in 1 BOTTLE (71335-0854-3) 100 tablet2022-04-110000-00-00NoNoCurrent
71335-0854-47133508540490 TABLET in 1 BOTTLE (71335-0854-4) 90 tablet2018-06-110000-00-00NoNoCurrent