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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076430-001 | BENAZEPRIL HYDROCHLORIDE | 5MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076430-002 | BENAZEPRIL HYDROCHLORIDE | 10MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076430-003 | BENAZEPRIL HYDROCHLORIDE | 20MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076430-004 | BENAZEPRIL HYDROCHLORIDE | 40MG | TABLET / ORAL | 2004-02-11 | 84e616aacf4f… | ||
| 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… |
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 | AvPAK | f004d7e2-fc45-8a37-e548-eeaaa327f9b5 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 6c24bb4c-42d2-483a-b33f-95182b32b93d | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | fade97e1-8400-4214-b750-e7656cae7a0f | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 910dac3a-728c-4f94-a514-e2b8f4680d39 | 2025-05-27 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 91a3d0f7-d2df-4230-ad9e-b32f7312d337 | 2025-05-19 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | A-S Medication Solutions | 8f46e2c9-9b3b-48d0-a307-9069e3879959 | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Golden State Medical Supply, Inc. | cb93e793-fe4f-452c-e053-2995a90a7333 | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1a7b373a-9b74-4b9d-93fb-081614222e30 | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 355811f0-2885-0d49-e054-00144ff8d46c | 2025-03-06 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 55c99902-3d4d-05e9-e054-00144ff8d46c | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 4d5a8b50-dd2f-4329-9e28-93608e8fe8da | 2025-01-24 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| BENAZEPRIL HYDROCHLORIDE | BENAZEPRIL HYDROCHLORIDE | DIRECT RX | a7e4e43a-7abc-e2a5-e053-2995a90ab5f4 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | BENAZEPRIL HYDROCHLORIDE BENAZEPRIL HYDROCHLORIDE |
| Benazepril hydrochloride | BENAZEPRIL HYDROCHLORIDE | Chartwell RX, LLC | df13d8d8-0d70-4d6f-9dd1-5da38fbe2562 | 2024-10-10 | Boxed warning, Warnings, Adverse reactions | Benazepril hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 08bc0034-3b33-47d8-aec2-b36535ac85a2 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Bryant Ranch Prepack | 0653322d-70c6-45f7-a9d1-41efee1d7387 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 7274fdaf-1247-2b2f-e053-2991aa0ad3f6 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 700c828c-86c6-1857-e053-2a91aa0ae314 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 9535ec77-2d50-4817-e053-2995a90a007e | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 53fea330-cc4a-3b7e-e054-00144ff88e88 | 2024-07-09 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
| Benazepril Hydrochloride | BENAZEPRIL HYDROCHLORIDE | Proficient Rx LP | be41d21c-4747-47bb-b4b7-bbfabcd7a9b1 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | Benazepril Hydrochloride BENAZEPRIL HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |