Application 075752
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 2.5MG | No | No |
| 002 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 5MG | No | No |
| 003 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 10MG | No | No |
| 004 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 20MG | No | No |
| 005 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 30MG | No | No |
| 006 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075752-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | ||
| A075752-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | ||
| A075752-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | ||
| A075752-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | ||
| A075752-005 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | ||
| A075752-006 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 |
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 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075752-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A075752-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075752-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A075752-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075752-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A075752-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075752-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075752-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075752-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075752-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075752-005 | LISINOPRIL | 30MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075752-006 | LISINOPRIL | 40MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075752-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075752-002 | LISINOPRIL | 5MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075752-003 | LISINOPRIL | 10MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075752-004 | LISINOPRIL | 20MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | A075752-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075752-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075752-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075752-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075752-005 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A075752-006 | AB | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075752-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075752-002 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075752-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075752-004 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075752-005 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075752-006 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075752-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075752-002 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075752-003 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075752-004 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075752-005 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075752-006 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A075752-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A075752-002 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A075752-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A075752-004 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A075752-005 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A075752-006 | AB | 1 | 053a50430f4f… |
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 |
|---|---|---|---|---|---|---|
| LISINOPRIL | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | 03a497fe-fb09-4b2c-8ee0-2019600192b8 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | dd015c18-1ea6-44e3-9186-8d2f8444d874 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | PD-Rx Pharmaceuticals, Inc. | e4c11545-00da-4675-856a-7e600a2f4bd9 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | cced442b-8047-4489-95d6-0700a66fba34 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | fbd3bde1-ee64-126f-e053-6394a90a9b6d | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | fbfa23c2-dae0-4f45-e053-6394a90a4fef | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 964c7f28-f62e-30b5-e053-2a95a90ab84c | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 9ba3610b-de5c-fa33-e053-2a95a90acbc5 | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Zestril | LISINOPRIL | Upsher-Smith Laboratories, LLC | 838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Quality Care Products LLC | 29e9ac54-f9da-495c-9102-2aac2cc7d88a | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Quality Care Products LLC | babb75f0-bccc-44e8-955a-6873344ccc21 | 2024-12-17 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4f1f76fe-816c-384a-e054-00144ff88e88 | 2024-12-03 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | NCS HealthCare of KY, LLC dba Vangard Labs | 3121a4c6-d5c2-4608-a0be-2d9f4b955d5f | 2024-10-18 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 8f63c3e0-0b3f-4a04-a592-2ce10dfda202 | 2024-10-15 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 06ca101e-4498-4c4e-b455-01915e7ecca0 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 24f532f2-c41e-4d1d-989e-7a56b60fbdd4 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 0bf433cb-bf7d-4b41-9518-400646f9aa2a | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | bebf037f-10f8-4e1f-a512-614f81deb891 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 37aa2542-de44-401b-a6ff-96d2e07914c7 | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 33ebf3f2-cd71-4d8b-ac22-1a20a068a13d | 2024-10-07 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
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 |
|---|---|---|---|---|---|
| 0615-5521 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5530 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5531 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5538 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5539 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-5540 | Lisinopril | Lisinopril | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 23155-710 | Lisinopril | Lisinopril | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-711 | Lisinopril | Lisinopril | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-712 | Lisinopril | Lisinopril | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-713 | Lisinopril | Lisinopril | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-714 | Lisinopril | Lisinopril | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-715 | Lisinopril | Lisinopril | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 53808-0379 | Lisinopril | Lisinopril | State of Florida DOH Central Pharmacy | ANDA | Current |
| 66116-310 | Lisinopril | Lisinopril | MedVantx, Inc. | ANDA | Current |
| 66116-391 | Lisinopril | Lisinopril | MedVantx, Inc. | ANDA | Current |
| 66116-841 | Lisinopril | Lisinopril | MedVantx, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31006 | ORIG | 2003-04-15 |