Application 076262
- Type
- ANDA
- Sponsor
- SANDOZ
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 |
|---|---|---|---|---|---|---|---|
| A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076262-001 | AB |
| A076262-002 | AB |
| A076262-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076262-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076262-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076262-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076262-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076262-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076262-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076262-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076262-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076262-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076262-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076262-003 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076262-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076262-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076262-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076262-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076262-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076262-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076262-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076262-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076262-003 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076262-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076262-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076262-003 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076262-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076262-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076262-003 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076262-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076262-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076262-003 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076262-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076262-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076262-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076262-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076262-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A076262-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076262-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076262-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A076262-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076262-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076262-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A076262-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076262-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076262-002 | AB | 1 | 3f01610625f2… |
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 TABLETS | REMEDYREPACK INC. | 3bea11a3-eb07-46b2-9b91-f8a48a2f3b7e | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Proficient Rx LP | 43a4d6dd-bcca-412c-b051-ed470208ddb6 | 2026-08-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aurobindo Pharma Limited | d7214539-6c3d-466a-a474-6fde096fa182 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | St. Mary's Medical Park Pharmacy | e1aa9682-b1ad-4a22-e053-2a95a90a0e2f | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 3857ac53-0435-4d68-8066-c22291414889 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 868b1442-c412-4ee8-9798-f2408cd2249a | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 408e797a-2cf3-4ee6-9f9b-179a8cf3d799 | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | St. Mary's Medical Park Pharmacy | 00b266d9-ac4a-e931-e063-6294a90a6a0b | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Coupler LLC | 52b90789-2902-3ab9-e063-6394a90a5abb | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Preferred Pharmaceuticals Inc. | 5956a107-0f7b-49e7-b9c9-36790349b06e | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals, Inc. | 5aa18b0b-4688-493a-a5ae-cb056ea6c0e3 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Preferred Pharmaceuticals Inc. | 9207c3bc-e12e-4017-8b85-0f928e744f64 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Preferred Pharmaceuticals Inc. | fc4d7d0e-78a6-4d7e-ba53-aeeb008aa2dc | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 544b75eb-55f1-4164-9b83-39f6bc5fb479 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 019ac336-0dc3-ec89-3e0a-09110e0fc30b | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | eac8c44f-cf77-6a30-cfd7-7cffffc79bd6 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | St Marys Medical Park Pharmacy | e7b68ea6-4fc8-441a-9640-1ccd3a482d8e | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Legacy Pharmaceutical Packaging, LLC | 6d729ec5-7311-4534-9999-9d6fa4f3ba2f | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | A-S Medication Solutions | 7d4ee5ec-5b68-453b-8d6e-214457a58159 | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | A-S Medication Solutions | 62e8c093-cd8e-4342-aadb-209c7e6699c8 | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
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 |
|---|---|---|---|---|---|
| 0185-0152 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0152 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0173 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-0173 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-7100 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 0185-7100 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Eon Labs, Inc. | ANDA | Current |
| 42291-390 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 42291-391 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | AvKARE, Inc. | ANDA | Current |
| 43353-865 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-866 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-867 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2634 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | A-S Medication Solutions | ANDA | Current |
| 70518-0604 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 70518-0604 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | REMEDYREPACK INC. | ANDA | Current |
| 71335-0230 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0230 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0230 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0537 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0537 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0537 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0576 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |
| 71335-0576 | Lisinopril and Hydrochlorothiazide | Lisinopril and Hydrochlorothiazide | Bryant Ranch Prepack | ANDA | Current |