Benazepril Hydrochloride

Product NDC
50090-3359
11-digit product format
500903359
Labeler code
50090
Product ID
50090-3359_4a6b0e09-3f06-4d54-8ea6-ce8e130f37d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078212
Marketing category
ANDA
Marketing start
2008-05-22
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
40 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078212-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22
A078212-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22
A078212-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078212-001AB
A078212-002AB
A078212-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-002BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-003BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALABRS2008-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078212-001BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-221e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078212-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078212-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078212-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078212-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078212-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078212-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078212-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078212-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078212-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078212-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078212-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078212-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078212-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078212-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078212-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078212-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078212-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078212-001AB11e350fbaab3a…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE40 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
898719Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c5090372-41bf-4677-b198-97fd55a0cb87Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3359-0Benazepril Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
50090-3359-1Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3359-0EA - Each50090-335902366247-ebd1-4669-a3b6-e3f5390de9ef12019-05-02
50090-3359-1EA - Each50090-335912bc33c0-1403-4c4a-8ee6-7775e67e1c9e12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3359BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230208_c5090372-41bf-4677-b198-97fd55a0cb87.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEBryant Ranch Prepack58977ec4-36ea-4d81-a8f0-7298425cbc842026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited09e383a8-e912-4cf7-8fb3-05545af80dd02026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEAurobindo Pharma Limited67c64de1-5579-46e4-82ee-c9bbee708e022026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf7f9dc46-a947-7ae3-e053-6394a90a11922026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCfc4cd253-13ee-9424-e053-6394a90a35a82026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENorthwind Health Company, LLCf32d01db-655b-f3d0-e053-2a95a90a04f62026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsfade97e1-8400-4214-b750-e7656cae7a0f2025-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.91a3d0f7-d2df-4230-ad9e-b32f7312d3372025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.9016634a-1bdd-700d-e053-2995a90a8f272024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDENuCare Pharmaceuticals,Inc.800f2a14-98b9-3499-e053-2991aa0a197d2024-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutionse0d5362b-f5da-4838-ae91-22f40fcca2452023-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc5090372-41bf-4677-b198-97fd55a0cb872023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212
ndc (product): 50090-3359
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEProficient Rx LP92a26516-3d84-4d7a-a770-5239265078872019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSNc5090372-41bf-4677-b198-97fd55a0cb875
898719benazepril hydrochloride 40 MG Oral TabletSCDc5090372-41bf-4677-b198-97fd55a0cb875
898719BZP hydrochloride 40 MG Oral TabletSYc5090372-41bf-4677-b198-97fd55a0cb875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3359-05009033590030 TABLET, FILM COATED in 1 BOTTLE (50090-3359-0) 2018-03-260000-00-00NoNoCurrent
50090-3359-15009033590190 TABLET, FILM COATED in 1 BOTTLE (50090-3359-1) 2018-02-020000-00-00NoNoCurrent