Lisinopril and Hydrochlorothiazide
- Product NDC
- 0591-0861
- 11-digit product format
- 005910861
- Labeler code
- 0591
- Product ID
- 0591-0861_ab203e31-9939-4e72-8ccd-ed55261bfb65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lisinopril and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA076194
- Marketing category
- ANDA
- Marketing start
- 2003-03-04
- Substance
- HYDROCHLOROTHIAZIDE; LISINOPRIL
- Active strength
- 12.5; 20 mg/1; mg/1
- Pharmacologic classes
- Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 0591-0861 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 | ||
| unfinished package | package | 0591-0861 | 0591-0861-00 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-03 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 0591-0861-00 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 0591-0861-00 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 0591-0861-00 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 0591-0861-00 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 0591-0861-00 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 0591-0861-00 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 0591-0861-00 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 0591-0861-00 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 0591-0861-00 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 0591-0861-00 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 0591-0861-00 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 0591-0861-00 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 0591-0861-00 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 0591-0861-00 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 0591-0861-00 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 0591-0861-00 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 0591-0861-00 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 0591-0861-00 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 0591-0861-00 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 0591-0861-00 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 0591-0861-00 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | |
| A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; LISINOPRIL | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076194-001 | AB |
| A076194-002 | AB |
| A076194-003 | 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 | A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076194-001 | 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 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076194-002 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 25MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076194-003 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;10MG | TABLET / ORAL | AB | 2002-07-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076194-001 | LISINOPRIL AND HYDROCHLOROTHIAZIDE | 12.5MG;20MG | TABLET / ORAL | AB | 2002-07-01 | 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 | A076194-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076194-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076194-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076194-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076194-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076194-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076194-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076194-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076194-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076194-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076194-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076194-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076194-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076194-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076194-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076194-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076194-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076194-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076194-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076194-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076194-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076194-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076194-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076194-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076194-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076194-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076194-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076194-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076194-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076194-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076194-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076194-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076194-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076194-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076194-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076194-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076194-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076194-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076194-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076194-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lisinopril and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LISINOPRIL | 12.5 mg/1 |
| HYDROCHLOROTHIAZIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| E7199S1YWR | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-0861-01 | Lisinopril and Hydrochlorothiazide | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 29 | |
| 0591-0861-05 | Lisinopril and Hydrochlorothiazide | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 29 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0861-01 | EA - Each | 0591-0861 | 1b7e89fb-9e07-4047-986d-593647c00418 | 1 | 2012-07-24 |
| 0591-0861-05 | EA - Each | 0591-0861 | e9306829-dab3-4f30-9d0a-f7c50b541bf8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Northwind Health Company, LLC | 3d801e51-e675-45eb-bc7e-407e610f4009 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | QPharma Inc | ff7b2d81-9006-465d-9095-1bd8696a12a6 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
| Lisinopril and hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | NuCarePharmaceuticals, Inc. | 4fbf31a1-037b-31a2-e054-00144ff88e88 | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 6c57bf12-9ad5-3a25-e053-2a91aa0aaf26 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 2b66693d-0514-4f41-b405-bd3dd7618e81 | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
| Lisinopril and hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Proficient Rx LP | af0b3bef-be36-432a-884e-ea81e2d5c08e | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Actavis Pharma, Inc. | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 2020-05-01 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 0591-0861 |
| Lisinopril and Hydrochlorothiazide | LISINOPRIL AND HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 5eea66bd-589a-45f8-ba2c-dea66a939d59 | 2019-05-13 | Boxed warning, Warnings, Adverse reactions | 076194 ANDA076194 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 2b66693d-0514-4f41-b405-bd3dd7618e81 | 102 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 2b66693d-0514-4f41-b405-bd3dd7618e81 | 102 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 2b66693d-0514-4f41-b405-bd3dd7618e81 | 102 |
| 197885 | lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197887 | lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197885 | hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet | SCD | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197887 | hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet | SCD | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197885 | HCTZ 12.5 MG / lisinopril 10 MG Oral Tablet | SY | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197887 | HCTZ 25 MG / lisinopril 20 MG Oral Tablet | SY | ab5e9ae4-e575-4a63-99f3-2bde36bdd508 | 29 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | af0b3bef-be36-432a-884e-ea81e2d5c08e | 6 |
| 197887 | lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | af0b3bef-be36-432a-884e-ea81e2d5c08e | 6 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | af0b3bef-be36-432a-884e-ea81e2d5c08e | 6 |
| 197887 | hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet | SCD | af0b3bef-be36-432a-884e-ea81e2d5c08e | 6 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | af0b3bef-be36-432a-884e-ea81e2d5c08e | 6 |
| 197887 | HCTZ 25 MG / lisinopril 20 MG Oral Tablet | SY | af0b3bef-be36-432a-884e-ea81e2d5c08e | 6 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 6c57bf12-9ad5-3a25-e053-2a91aa0aaf26 | 5 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 6c57bf12-9ad5-3a25-e053-2a91aa0aaf26 | 5 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 6c57bf12-9ad5-3a25-e053-2a91aa0aaf26 | 5 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 3d801e51-e675-45eb-bc7e-407e610f4009 | 3 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 37125cf9-34ec-4979-a610-a71bd12323f4 | 3 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 37125cf9-34ec-4979-a610-a71bd12323f4 | 3 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 3d801e51-e675-45eb-bc7e-407e610f4009 | 3 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 37125cf9-34ec-4979-a610-a71bd12323f4 | 3 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 3d801e51-e675-45eb-bc7e-407e610f4009 | 3 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 8f8cfb63-073c-c156-e053-2995a90a61e7 | 2 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 80221abf-6e01-c8c2-e053-2a91aa0a82b8 | 2 |
| 205326 | lisinopril 30 MG Oral Tablet | PSN | 80221abf-6e01-c8c2-e053-2a91aa0a82b8 | 2 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 8f8cfb63-073c-c156-e053-2995a90a61e7 | 2 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 80221abf-6e01-c8c2-e053-2a91aa0a82b8 | 2 |
| 205326 | lisinopril 30 MG Oral Tablet | SCD | 80221abf-6e01-c8c2-e053-2a91aa0a82b8 | 2 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 8f8cfb63-073c-c156-e053-2995a90a61e7 | 2 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 80221abf-6e01-c8c2-e053-2a91aa0a82b8 | 2 |
| 197885 | lisinopril 10 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 5eea66bd-589a-45f8-ba2c-dea66a939d59 | 1 |
| 197886 | lisinopril 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet | PSN | 9348361e-8de9-4455-91c4-5586037dcfea | 1 |
| 197887 | lisinopril 20 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197885 | hydrochlorothiazide 12.5 MG / lisinopril 10 MG Oral Tablet | SCD | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 5eea66bd-589a-45f8-ba2c-dea66a939d59 | 1 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 9348361e-8de9-4455-91c4-5586037dcfea | 1 |
| 197886 | hydrochlorothiazide 12.5 MG / lisinopril 20 MG Oral Tablet | SCD | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197887 | hydrochlorothiazide 25 MG / lisinopril 20 MG Oral Tablet | SCD | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197885 | HCTZ 12.5 MG / lisinopril 10 MG Oral Tablet | SY | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 9348361e-8de9-4455-91c4-5586037dcfea | 1 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 5eea66bd-589a-45f8-ba2c-dea66a939d59 | 1 |
| 197886 | HCTZ 12.5 MG / lisinopril 20 MG Oral Tablet | SY | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
| 197887 | HCTZ 25 MG / lisinopril 20 MG Oral Tablet | SY | 63fa5147-fb3e-47ec-bea1-a80e1f551866 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-0861-00 | 00591086100 | 25000 TABLET in 1 BAG (0591-0861-00) | 25000 tablet | 01-MAR-03 | Current | |||
| 0591-0861-01 | 00591086101 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-0861-01) | 100 tablet | 2003-03-04 | 0000-00-00 | No | No | Current |
| 0591-0861-05 | 00591086105 | 500 TABLET in 1 BOTTLE, PLASTIC (0591-0861-05) | 500 tablet | 2003-03-04 | 0000-00-00 | No | No | Current |