Triamterene and Hydrochlorothiazide
- Product NDC
- 0591-0424
- 11-digit product format
- 005910424
- Labeler code
- 0591
- Product ID
- 0591-0424_31975473-b876-48d4-81f4-b322137d8900
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Triamterene and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA073449
- Marketing category
- ANDA
- Marketing start
- 1993-09-23
- Substance
- HYDROCHLOROTHIAZIDE; TRIAMTERENE
- Active strength
- 25; 37.5 mg/1; mg/1
- Pharmacologic classes
- Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], 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 | 0591-0424 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 | ||
| unfinished package | package | 0591-0424 | 0591-0424-00 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 | |
| unfinished package | package | 0591-0424 | 0591-0424-77 | UNFINISHED | Active or certified unfinished drug listing | 2026-08-17 |
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 | 0591-0424-00 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | 1d862106b807… | 00c93037cd84… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | e30019b0c005… | a3f0b14938b7… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | f764e8902f78… | 92046438deef… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-00 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 0591-0424-77 | 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 | 0591-0424-77 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 0591-0424-00 | 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 | 0591-0424-77 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 0591-0424-00 | 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 | 0591-0424-77 | 27f29a85d7e4… | 1372111e901f… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 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 | 0591-0424-00 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A073449-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A073449-001 | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | 25MG;37.5MG | TABLET / ORAL | AB | 1993-09-23 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A073449-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A073449-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A073449-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A073449-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A073449-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A073449-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A073449-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A073449-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A073449-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A073449-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A073449-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A073449-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A073449-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A073449-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A073449-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A073449-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A073449-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A073449-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A073449-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A073449-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A073449-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A073449-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A073449-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A073449-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A073449-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A073449-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A073449-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A073449-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A073449-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A073449-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A073449-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A073449-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A073449-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A073449-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A073449-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A073449-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A073449-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A073449-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A073449-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A073449-001 | AB | 1 | e64feba35796… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Triamterene and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TRIAMTERENE | 25 mg/1 |
| HYDROCHLOROTHIAZIDE | 37.5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
| WS821Z52LQ | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| abf2fe45-8b69-4d3c-981e-289c0aa3e98b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-0424-01 | Triamterene and Hydrochlorothiazide | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 17 | |
| 0591-0424-05 | Triamterene and Hydrochlorothiazide | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0424-01 | EA - Each | 0591-0424 | 479b914e-4724-4955-9dca-043a305d74ac | 1 | 2012-07-24 |
| 0591-0424-05 | EA - Each | 0591-0424 | 30863731-fc36-4456-a9db-6e200a57f9fd | 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 |
|---|---|---|---|---|---|---|
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 43425ec7-a2c0-41d8-b759-b7b5918949ce | 2026-06-01 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | bdd4348d-928d-ef0b-e053-2a95a90aadb4 | 2026-02-20 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals, Inc. | 6c4cd90b-44c0-4da5-8f26-f0fa465acce4 | 2026-01-13 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | e505484d-b600-4d13-a4b9-278dc4a2e73a | 2025-10-20 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | A-S Medication Solutions | f4f026f9-5f21-435e-8878-01dc9bbe2d66 | 2025-07-10 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 5f5c3ada-db41-4104-9bed-9a56439a7ea2 | 2024-10-07 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 7c214ebf-e0ed-6538-e053-2991aa0a8079 | 2024-07-16 | Warnings, Adverse reactions | 073449 ANDA073449 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | Actavis Pharma, Inc. | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 2024-05-01 | Warnings, Adverse reactions | 073449 ANDA073449 0591-0424 |
| Triamterene and Hydrochlorothiazide | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | BluePoint Laboratories | b8a55c23-b509-4790-88fa-9dc9bacd4bbe | 2024-03-29 | Warnings, Adverse reactions | 073449 ANDA073449 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | e505484d-b600-4d13-a4b9-278dc4a2e73a | 21 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | e505484d-b600-4d13-a4b9-278dc4a2e73a | 21 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | e505484d-b600-4d13-a4b9-278dc4a2e73a | 21 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 17 |
| 310818 | triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral Tablet | PSN | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 17 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 17 |
| 310818 | hydrochlorothiazide 50 MG / triamterene 75 MG Oral Tablet | SCD | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 17 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 17 |
| 310818 | HCTZ 50 MG / triamterene 75 MG Oral Tablet | SY | abf2fe45-8b69-4d3c-981e-289c0aa3e98b | 17 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | f4f026f9-5f21-435e-8878-01dc9bbe2d66 | 13 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | f4f026f9-5f21-435e-8878-01dc9bbe2d66 | 13 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | f4f026f9-5f21-435e-8878-01dc9bbe2d66 | 13 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 6c4cd90b-44c0-4da5-8f26-f0fa465acce4 | 7 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 6c4cd90b-44c0-4da5-8f26-f0fa465acce4 | 7 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 6c4cd90b-44c0-4da5-8f26-f0fa465acce4 | 7 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 5f5c3ada-db41-4104-9bed-9a56439a7ea2 | 6 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 5f5c3ada-db41-4104-9bed-9a56439a7ea2 | 6 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 5f5c3ada-db41-4104-9bed-9a56439a7ea2 | 6 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | f7078eb5-f5fa-4067-94c5-93c1650db52c | 5 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | f7078eb5-f5fa-4067-94c5-93c1650db52c | 5 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | f7078eb5-f5fa-4067-94c5-93c1650db52c | 5 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 4e7af293-8d6e-41b0-e054-00144ff8d46c | 4 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 7c214ebf-e0ed-6538-e053-2991aa0a8079 | 4 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 7c214ebf-e0ed-6538-e053-2991aa0a8079 | 4 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 4e7af293-8d6e-41b0-e054-00144ff8d46c | 4 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 7c214ebf-e0ed-6538-e053-2991aa0a8079 | 4 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 4e7af293-8d6e-41b0-e054-00144ff8d46c | 4 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 75d80f11-5c51-df34-e053-2991aa0a67c2 | 3 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 75d80f11-5c51-df34-e053-2991aa0a67c2 | 3 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 75d80f11-5c51-df34-e053-2991aa0a67c2 | 3 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | bdd4348d-928d-ef0b-e053-2a95a90aadb4 | 2 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | bdd4348d-928d-ef0b-e053-2a95a90aadb4 | 2 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | bdd4348d-928d-ef0b-e053-2a95a90aadb4 | 2 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 58912e7f-e2a2-44a5-ad38-31f95bbb9509 | 1 |
| 310812 | triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral Tablet | PSN | 11a76fc1-5a1e-0509-e054-00144ff88e88 | 1 |
| 310818 | triamterene 75 MG / hydroCHLOROthiazide 50 MG Oral Tablet | PSN | 11a76fc1-5a1e-0509-e054-00144ff88e88 | 1 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 58912e7f-e2a2-44a5-ad38-31f95bbb9509 | 1 |
| 310812 | hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral Tablet | SCD | 11a76fc1-5a1e-0509-e054-00144ff88e88 | 1 |
| 310818 | hydrochlorothiazide 50 MG / triamterene 75 MG Oral Tablet | SCD | 11a76fc1-5a1e-0509-e054-00144ff88e88 | 1 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 58912e7f-e2a2-44a5-ad38-31f95bbb9509 | 1 |
| 310812 | HCTZ 25 MG / triamterene 37.5 MG Oral Tablet | SY | 11a76fc1-5a1e-0509-e054-00144ff88e88 | 1 |
| 310818 | HCTZ 50 MG / triamterene 75 MG Oral Tablet | SY | 11a76fc1-5a1e-0509-e054-00144ff88e88 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0591-0424-00 | 00591042400 | 49800 TABLET in 1 BAG (0591-0424-00) | 49800 tablet | 23-SEP-93 | 31-MAR-28 | Historical | ||
| 0591-0424-01 | 00591042401 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-0424-01) | 100 tablet | 1993-09-23 | 0000-00-00 | No | No | Current |
| 0591-0424-05 | 00591042405 | 500 TABLET in 1 BOTTLE, PLASTIC (0591-0424-05) | 500 tablet | 1993-09-23 | 0000-00-00 | No | No | Current |
| 0591-0424-77 | 00591042477 | 59700 TABLET in 1 CONTAINER (0591-0424-77) | 59700 tablet | 31-JUL-24 | 30-JUN-28 | Historical |