Application 076113
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | ||
| A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | ||
| A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | 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 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076113-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | 2002-07-01 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076113-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | 2002-07-01 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076113-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | 2002-07-01 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A076113-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076113-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076113-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A076113-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076113-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076113-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076113-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076113-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076113-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076113-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076113-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076113-003 | AB | 1 | ea99ee380514… |
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 | Proficient Rx LP | af0b3bef-be36-432a-884e-ea81e2d5c08e | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | 2bcd9e20-2839-4cc0-9d1d-74b2cf17a96e | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| LISINOPRIL AND HYDROCHLOROTHIAZIDE | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | d9895efd-fb9d-4ce9-818a-31d724b16295 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | LISINOPRIL AND HYDROCHLOROTHIAZIDE |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Cipla USA Inc. | 40e6b627-63dc-4d52-aaa8-750663ad86c2 | 2021-11-05 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Actavis Pharma, Inc. | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 2020-05-01 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS | Aphena Pharma Solutions - Tennessee, LLC | e2903227-4a79-4a9c-b96b-073b8e41fb01 | 2020-01-13 | Boxed warning, Warnings, Adverse reactions | Lisinopril and Hydrochlorothiazide |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 5eea66bd-589a-45f8-ba2c-dea66a939d59 | 2019-05-13 | 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 |
|---|---|---|---|---|---|
| 0378-1012 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1012 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-2012 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2012 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-2025 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-2025 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Mylan Pharmaceuticals Inc | ANDA | Current |
| 43353-968 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-968 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-976 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-976 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-976 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-977 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-977 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 60429-201 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-201 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-201 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-201 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-202 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-202 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-202 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-203 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-203 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-203 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Golden State Medical Supply, Inc. | ANDA | Current |
| 67544-250 | Lisinopril and Hydrochlorothiazide | lisinopril and hydrochlorothiazide | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31077 | ORIG | 2003-04-10 |