Benazepril hydrochloride

Product NDC
70771-1148
11-digit product format
707711148
Labeler code
70771
Product ID
70771-1148_5858760b-c49d-45f3-865a-ddb5533bdc68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078848
Marketing category
ANDA
Marketing start
2017-11-13
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 productproduct70771-1148DDiscontinued by firm2026-10-21
excluded packagepackage70771-114870771-1148-0DDiscontinued by firm2026-10-21
excluded packagepackage70771-114870771-1148-1DDiscontinued by firm2026-10-21
excluded packagepackage70771-114870771-1148-9DDiscontinued by firm2026-10-21

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 · 8 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 packagepackage70771-1148-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1148-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70771-1148-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1148-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1148-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70771-1148-1f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A078848-001BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-23
A078848-002BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-23
A078848-003BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-23
A078848-004BENAZEPRIL HYDROCHLORIDEBENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A078848-001AB
A078848-002AB
A078848-003AB
A078848-004AB

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-23c2088c7a36db…
2026-10-15 13:18:302026-09A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-23c2088c7a36db…
2026-10-15 13:18:302026-09A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-23c2088c7a36db…
2026-10-15 13:18:302026-09A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-23c2088c7a36db…
2026-09-14 22:38:342026-08A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2384e616aacf4f…
2026-09-14 22:38:342026-08A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-2384e616aacf4f…
2026-08-18 06:07:402026-07A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078848-001BENAZEPRIL HYDROCHLORIDE5MGTABLET / ORALAB2008-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078848-002BENAZEPRIL HYDROCHLORIDE10MGTABLET / ORALAB2008-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078848-003BENAZEPRIL HYDROCHLORIDE20MGTABLET / ORALAB2008-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078848-004BENAZEPRIL HYDROCHLORIDE40MGTABLET / ORALAB2008-05-232680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078848-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078848-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078848-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078848-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078848-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078848-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078848-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078848-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078848-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078848-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078848-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078848-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078848-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078848-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078848-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078848-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078848-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078848-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078848-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078848-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078848-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078848-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078848-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078848-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078848-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078848-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078848-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078848-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078848-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078848-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078848-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078848-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078848-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078848-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078848-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078848-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078848-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078848-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078848-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078848-004AB14b0b4de00fa7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1148BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]5Legacy NDC20221109_2e04ce38-7f44-49d1-9471-a0141631594e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1148-0707711148001000 TABLET, FILM COATED in 1 BOTTLE (70771-1148-0) 2017-11-130000-00-00NoNoCurrent
70771-1148-170771114801100 TABLET, FILM COATED in 1 BOTTLE (70771-1148-1) 2017-11-130000-00-00NoNoCurrent
70771-1148-97077111480990 TABLET, FILM COATED in 1 BOTTLE (70771-1148-9) 2017-11-130000-00-00NoNoCurrent