Application 076430
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 20MG | No | No |
| 004 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076430-001 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | ||
| A076430-002 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | ||
| A076430-003 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | ||
| A076430-004 | BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076430-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076430-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076430-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076430-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076430-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076430-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076430-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076430-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076430-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076430-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076430-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076430-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076430-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076430-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076430-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076430-004 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | e0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | ff732cfa-9ded-4226-b464-19c90a6865ae | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | afd616b9-0c75-48be-862d-5ac18364fd9d | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 58977ec4-36ea-4d81-a8f0-7298425cbc84 | 2026-06-05 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5de2ea54-877d-46e9-b4c2-bf1ab9d0f19c | 2026-05-14 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | REMEDYREPACK INC. | 6dc12ab4-2282-412f-8aa1-46ec5fbbab8f | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Cardinal Health 107, LLC | f265e6dd-f47e-4511-9468-282184bcd1b1 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 01a3c9f6-41aa-47a7-8c56-5462c6b54416 | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 032ea0f7-3304-4778-b3a6-6125ea7537ab | 2026-03-19 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 09e383a8-e912-4cf7-8fb3-05545af80dd0 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 7aac6a2f-85fb-4c7a-b424-9c253186dffe | 2026-03-03 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Aurobindo Pharma Limited | 67c64de1-5579-46e4-82ee-c9bbee708e02 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f7f9dc46-a947-7ae3-e053-6394a90a1192 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | fc4cd253-13ee-9424-e053-6394a90a35a8 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f32d01db-655b-f3d0-e053-2a95a90a04f6 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | f99d3d0d-cee8-b260-e053-6294a90ac3cb | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | 3631d1dc-45e1-0588-e054-00144ff88e88 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | 708110e5-fa45-44e0-9011-261f4490ea45 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Northwind Health Company, LLC | 471cd30a-401a-c8f9-e063-6294a90a4787 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Lotensin | BENAZEPRIL HYDROCHLORIDE | Validus Pharmaceuticals LLC | 2abb091b-a53e-46b0-9b84-e5ee8f2bdd8e | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | BENAZEPRIL HYDROCHLORIDE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-0441 | Benazepril Hydrochloride | benazepril hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0443 | Benazepril Hydrochloride | benazepril hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0444 | Benazepril Hydrochloride | benazepril hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-0447 | Benazepril Hydrochloride | benazepril hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 51079-145 | Benazepril Hydrochloride | benazepril hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-146 | Benazepril Hydrochloride | benazepril hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 55154-5672 | Benazepril Hydrochloride | benazepril hydrochloride | Cardinal Health | ANDA | Current |
| 55154-5673 | Benazepril Hydrochloride | benazepril hydrochloride | Cardinal Health | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8912 | ORIG | 2004-02-27 |