Benazepril Hydrochloride

Product NDC
68071-1146
11-digit product format
680711146
Labeler code
68071
Product ID
68071-1146_bb04b38a-bd19-e783-e053-2995a90a9498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
Marketing end
0000-00-00
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
2022-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-1146DDiscontinued by firm2026-08-17
excluded packagepackage68071-114668071-1146-2DDiscontinued by firm2026-08-17
excluded packagepackage68071-114668071-1146-3DDiscontinued by firm2026-08-17
excluded packagepackage68071-114668071-1146-6DDiscontinued by firm2026-08-17
excluded packagepackage68071-114668071-1146-9DDiscontinued 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 2 · 75 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-1146-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-1146-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-1146-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-1146-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-1146-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-1146-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-1146-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-1146-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-1146-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-1146-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-1146-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-1146-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-1146-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-1146-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-1146-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-1146-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-1146-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-1146-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-1146-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-1146-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-1146-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-1146-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-1146-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-1146-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-1146-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-1146-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-1146-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-1146-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-1146-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-1146-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-1146-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-1146-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-1146-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-1146-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-1146-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-1146-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-1146-6ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-1146-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-1146-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-1146-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-1146-6367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-1146-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-1146-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-1146-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-1146-6557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-1146-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-1146-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-1146-9557ba5c1ecfa…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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-1146-22024-05-28These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-32024-05-28These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-62024-05-28These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-92024-05-28These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-22023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-32023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-62023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-92023-01-30These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-22021-02-10These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-32021-02-10These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-62021-02-10These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-92021-02-10These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-22021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-32021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-62021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991
68071-1146-92021-01-29These highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL hydrochloride tablets, USP for oral use Initial U.S. Approval: 1991

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1146-268071114602120 TABLET in 1 BOTTLE (68071-1146-2) 120 tablet2017-05-170000-00-00NoNoCurrent
68071-1146-36807111460330 TABLET in 1 BOTTLE (68071-1146-3) 30 tablet2017-05-170000-00-00NoNoCurrent
68071-1146-66807111460660 TABLET in 1 BOTTLE (68071-1146-6) 60 tablet2017-05-170000-00-00NoNoCurrent
68071-1146-96807111460990 TABLET in 1 BOTTLE (68071-1146-9) 90 tablet2017-05-170000-00-00NoNoCurrent