Benazepril Hydrochloride

Product NDC
42291-160
11-digit product format
422910160
Labeler code
42291
Product ID
42291-160_d5799c3c-e448-7ecb-e053-2a95a90a3580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA076820
Marketing category
ANDA
Marketing start
2009-07-29
Marketing end
0000-00-00
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
5 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-160DDiscontinued by firm2026-08-17
excluded packagepackage42291-16042291-160-01DDiscontinued by firm2026-08-17
excluded packagepackage42291-16042291-160-50DDiscontinued by firm2026-08-17
excluded packagepackage42291-16042291-160-90DDiscontinued 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 · 48 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 packagepackage42291-160-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-160-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42291-160-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-160-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-160-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42291-160-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-160-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-160-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42291-160-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-160-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-160-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42291-160-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-160-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-160-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42291-160-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-160-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-160-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42291-160-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-160-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-160-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42291-160-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-160-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-160-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42291-160-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-160-900efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-160-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42291-160-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-160-90ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-160-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42291-160-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-160-90367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-160-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42291-160-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-160-90557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-160-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42291-160-01557ba5c1ecfa…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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-160-01EA - Each42291-160860cca43-ed35-40f2-9778-d6bec115ae9712016-11-08
42291-160-50EA - Each42291-160a712eff2-1e15-4eed-b243-fb10b4f7a1c212016-11-08
42291-160-90EA - Each42291-160fc2dffdf-a729-4db1-b809-4445b05879f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
CrospovidoneINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Magnesium StearateINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
Starch, CornINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9
TalcINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE TABLET [AVKARE, INC.]9

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
42291-160-0142291016001100 TABLET in 1 BOTTLE (42291-160-01) 100 tablet2016-09-070000-00-00NoNoCurrent
42291-160-5042291016050500 TABLET in 1 BOTTLE (42291-160-50) 500 tablet2016-09-070000-00-00NoNoCurrent