Benazepril Hydrochloride

Product NDC
68788-7845
11-digit product format
687887845
Labeler code
68788
Product ID
68788-7845_1cdb0a88-075b-4d5e-ae7b-4376732beddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticlas Inc.
Application
ANDA078212
Marketing category
ANDA
Marketing start
2021-01-20
Marketing end
0000-00-00
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
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7845DDiscontinued by firm2026-08-17
excluded packagepackage68788-784568788-7845-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-784568788-7845-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-784568788-7845-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-784568788-7845-8DDiscontinued by firm2026-08-17
excluded packagepackage68788-784568788-7845-9DDiscontinued by firm2026-08-17

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-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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7845-1EA - Each68788-7845b7197afc-362c-4811-9975-aa487f5e54fa12021-03-02
68788-7845-3EA - Each68788-784578e87eba-1c07-407c-b381-2609367eaa5012021-03-02
68788-7845-6EA - Each68788-784540cd58fc-ffc6-4444-ad3a-54ff4b86d64612021-03-02
68788-7845-8EA - Each68788-7845ed7a0895-fe57-4714-a89e-f1d1e149b92412021-03-02
68788-7845-9EA - Each68788-78451bd58012-1b80-431b-8a31-2da428dd10e812021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7845BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICLAS INC.]7Legacy NDC20250207_6d24bcc1-e5f4-4d65-9858-5fc583efe572.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
Benazepril HydrochlorideBENAZEPRIL HYDROCHLORIDEProficient Rx LP92a26516-3d84-4d7a-a770-5239265078872019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078212
application number: ANDA078212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7845-168788784501100 TABLET, FILM COATED in 1 BOTTLE (68788-7845-1) 2021-01-200000-00-00NoNoCurrent
68788-7845-36878878450330 TABLET, FILM COATED in 1 BOTTLE (68788-7845-3) 2021-01-200000-00-00NoNoCurrent
68788-7845-66878878450660 TABLET, FILM COATED in 1 BOTTLE (68788-7845-6) 2021-01-200000-00-00NoNoCurrent
68788-7845-868788784508120 TABLET, FILM COATED in 1 BOTTLE (68788-7845-8) 2021-01-200000-00-00NoNoCurrent
68788-7845-96878878450990 TABLET, FILM COATED in 1 BOTTLE (68788-7845-9) 2021-01-200000-00-00NoNoCurrent