Application 077912
- Type
- ANDA
- Sponsor
- LUPIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;10MG | No | No |
| 002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 12.5MG;20MG | No | No |
| 003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | TABLET;ORAL | 25MG;20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | |
| A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | |
| A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077912-001 | AB |
| A077912-002 | AB |
| A077912-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077912-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077912-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2006-09-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077912-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2006-09-27 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077912-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077912-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077912-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077912-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077912-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077912-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077912-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077912-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077912-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077912-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077912-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077912-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077912-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077912-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077912-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077912-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077912-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077912-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077912-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077912-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077912-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077912-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077912-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077912-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077912-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077912-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077912-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077912-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077912-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077912-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077912-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077912-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077912-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077912-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077912-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077912-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077912-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077912-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077912-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077912-001 | AB | 1 | 8072bd15b7f6… |
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 and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 3857ac53-0435-4d68-8066-c22291414889 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 868b1442-c412-4ee8-9798-f2408cd2249a | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 408e797a-2cf3-4ee6-9f9b-179a8cf3d799 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Coupler LLC | 52b90789-2902-3ab9-e063-6394a90a5abb | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals, Inc. | 5aa18b0b-4688-493a-a5ae-cb056ea6c0e3 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 544b75eb-55f1-4164-9b83-39f6bc5fb479 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 019ac336-0dc3-ec89-3e0a-09110e0fc30b | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | eac8c44f-cf77-6a30-cfd7-7cffffc79bd6 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | St Marys Medical Park Pharmacy | e7b68ea6-4fc8-441a-9640-1ccd3a482d8e | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Legacy Pharmaceutical Packaging, LLC | 6d729ec5-7311-4534-9999-9d6fa4f3ba2f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | 8808879d-8c7e-45d1-8a49-c05d2cf845d3 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 43063-458 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | 00f67e1a-6999-4295-9c9f-fcb1ce9711b8 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 43063-468 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | ec23c75d-68d5-46d0-be56-b96ddba19ed6 | 2026-01-07 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 43063-482 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f2b94985-c79d-40e3-e053-2a95a90a0d78 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | c97e38f2-7163-4d4e-a694-4d0612423e53 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 51655-412 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | 3984e6b9-2d88-47f0-af09-cce428bba14f | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 51655-413 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | QPharma, Inc. | c80b2164-3795-6668-e053-2a95a90a4d45 | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 42708-150 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lupin Pharmaceuticals, Inc. | 515f735c-5dba-43d9-8a58-97a319cafd56 | 2025-11-24 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | cd62e287-b648-459a-9414-621686c6b607 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 50090-2974 50090-2565 50090-1109 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 316e9226-e63e-466d-8143-f1edc7288fca | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 077912 ANDA077912 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-236 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-237 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-564 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Blenheim Pharmacal, Inc. | ANDA | Current |
| 33261-416 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-728 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-828 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-777 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-778 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 42708-150 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | QPharma Inc | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-458 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-468 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-482 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 49999-924 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-924 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Quality Care Products LLC | ANDA | Current |
| 49999-924 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-924 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-924 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-1109 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1109 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-1109 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2565 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2565 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2565 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2974 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2974 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2974 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2974 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50090-2974 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 50268-479 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-479 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-480 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-480 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-481 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50268-481 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvPAK | ANDA | Current |
| 50436-7000 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Unit Dose Services | ANDA | Current |
| 50436-8000 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Unit Dose Services | ANDA | Current |
| 50436-8900 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Unit Dose Services | ANDA | Current |
| 51655-412 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 51655-413 | Lisinopril and HCTZ | Lisinopril and Hydrochlorothiazide | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53002-1674 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2308 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 54458-886 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 54458-886 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 54458-991 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 54458-991 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 54458-992 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 54458-992 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 54458-993 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | International Laboratories, LLC | ANDA | Current |
| 57297-518 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |
| 57297-519 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | LUPIN LIMITED | ANDA | Current |