Application 075944
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
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 | 40MG | No | No |
| 006 | LISINOPRIL | LISINOPRIL | TABLET;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075944-001 | LISINOPRIL | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075944-002 | LISINOPRIL | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075944-003 | LISINOPRIL | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075944-004 | LISINOPRIL | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075944-005 | LISINOPRIL | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | |
| A075944-006 | LISINOPRIL | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075944-001 | AB |
| A075944-002 | AB |
| A075944-003 | AB |
| A075944-004 | AB |
| A075944-005 | AB |
| A075944-006 | AB |
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 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075944-005 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075944-006 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075944-005 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075944-006 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-005 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-006 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-005 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-006 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-005 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-006 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-005 | LISINOPRIL | 40MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-006 | LISINOPRIL | 30MG | TABLET / ORAL | AB | 2003-02-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-001 | LISINOPRIL | 2.5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-002 | LISINOPRIL | 5MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-003 | LISINOPRIL | 10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-004 | LISINOPRIL | 20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075944-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075944-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075944-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075944-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075944-005 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075944-006 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075944-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075944-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075944-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075944-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075944-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075944-006 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075944-006 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075944-006 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075944-006 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075944-006 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075944-004 | AB | 1 | b8a1b40f171c… |
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 43fa9a16-c112-419f-8d7b-177f580462f2 | 2024-09-23 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | American Health Packaging | 50ae0dfe-d961-4bc0-9898-71f69f9a5403 | 2024-09-12 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| Lisinopril | LISINOPRIL | Camber Pharmaceuticals, Inc. | 387068e7-7fb9-44f3-ae1c-e45ebc755a3e | 2024-08-29 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Solco healthcare U.S., LLC | e299d477-a612-4af4-b6aa-f5addc8a736d | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Bryant Ranch Prepack | 1ec55dd0-9ed5-40d2-978e-9fe773f2281a | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4aa518e1-d989-1fde-e054-00144ff88e88 | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 4aa44af9-1aff-314c-e054-00144ff8d46c | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 6f7f5697-acb0-ea95-e053-2991aa0ae7c7 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 6314e49c-8715-2f01-e053-2a91aa0ab2a5 | 2024-07-18 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | ab9bc1b4-60cc-76ea-e053-2995a90ac203 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 5a1c5b04-b78c-c057-e053-2991aa0aa916 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 5786b8d9-3818-66a5-e053-2991aa0a7025 | 2024-07-15 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals, Inc. | 51c80515-b26d-5776-e054-00144ff8d46c | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 90a589a9-acc2-bfbe-e053-2995a90a0bd2 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 9148529f-6278-e507-e053-2995a90aa4cf | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 95376981-4620-c9aa-e053-2995a90a1390 | 2024-06-19 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 86e7a336-c416-6fab-e053-2a91aa0a274c | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| Lisinopril | LISINOPRIL | NuCare Pharmaceuticals,Inc. | 7cd7c59d-ce52-1f5b-e053-2a91aa0a8f86 | 2024-06-12 | Boxed warning, Warnings, Adverse reactions | Lisinopril LISINOPRIL |
| LISINOPRIL | LISINOPRIL | Exelan Pharmaceuticals, Inc | 4aad4d30-3e18-489c-80ad-ccf7532bb933 | 2024-05-04 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL LISINOPRIL |
| LISINOPRIL | LISINOPRIL | A-S Medication Solutions | 54dc1e7e-6abd-4f6d-8b41-2b2731d51a65 | 2024-02-15 | 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 |
|---|---|---|---|---|---|
| 43063-138 | Lisinopril | Lisinopril | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0701 | Lisinopril | Lisinopril | State of Florida DOH Central Pharmacy | ANDA | Current |
| 63304-531 | Lisinopril | Lisinopril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-532 | Lisinopril | Lisinopril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-533 | Lisinopril | Lisinopril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-534 | Lisinopril | Lisinopril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-535 | Lisinopril | Lisinopril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 63304-599 | Lisinopril | Lisinopril | Ranbaxy Pharmaceuticals Inc. | ANDA | Current |
| 67046-426 | Lisinopril | Lisinopril | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-428 | Lisinopril | Lisinopril | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0542 | Lisinopril | Lisinopril | RedPharm Drug Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8841 | ORIG | 2004-06-24 |