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 | A-S Medication Solutions | cce5bcc0-2e38-41d8-a41e-4f4ea83e6248 | 2024-01-16 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 3783ab4c-2bed-414e-8927-62d47e3e3496 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Bryant Ranch Prepack | 5af2444f-438c-4ea6-96e8-3dba1af9e1a5 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | A-S Medication Solutions | 24aab432-9c51-4aee-b9b6-f38816d613bb | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | aeee8e9a-333a-416e-ab69-a0d40e146883 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Proficient Rx LP | 726a6f23-737a-4866-b4ba-b3c18cd2e1ac | 2024-01-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | a32db461-4f77-46ef-b49b-250711dade17 | 2023-12-20 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | a79a034d-7bbb-4b05-b8fc-8ebf09f33c0c | 2023-10-04 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | 719c4db7-ccbe-4779-baa7-a3c461f3aa52 | 2023-09-12 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Aphena Pharma Solutions - Tennessee, LLC | 021831ab-dfeb-40fc-aede-4aa1fbb8d918 | 2023-08-18 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| lisinopril | LISINOPRIL | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901) | c6c55efa-36bd-4613-98ca-2eb589a31e53 | 2023-07-18 | Boxed warning, Warnings, Adverse reactions | lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 3f6bc45e-448e-47f9-9bc4-991b1c503ddf | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | e5fbefd1-4077-4e81-a0e3-e09fadc48593 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | A-S Medication Solutions | 24f678c8-bb66-481e-b42b-1367cbff3169 | 2023-03-27 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | A-S Medication Solutions | 051375d4-7d38-45b3-9ca4-f2cd1f527b1b | 2023-03-13 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | b5683ac4-59dc-4772-8bc6-984c698afbeb | 2023-02-04 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | Proficient Rx LP | ad211de8-d236-48aa-bf27-4501eccfffca | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Solco healthcare U.S., LLC | f8d16c85-50e2-4d99-afae-6fb902734e42 | 2022-06-30 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Proficient Rx LP | b2d493bf-f4d8-4941-8c54-2728d769f6ed | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Proficient Rx LP | 3e4e69f6-b8a6-462d-a7ec-4cd6636512d0 | 2022-04-01 | 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 |