Hydrochlorothiazide
- Product NDC
- 0591-0347
- Requested package NDC
- 0591-0347-77
- 11-digit product format
- 005910347
- Labeler code
- 0591
- Product ID
- 0591-0347_aea91439-5b06-44b8-a92f-e75c13847c5d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA020504
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 1996-12-27
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 12.5 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 package | package | 0591-0347 | 0591-0347-77 | UNFINISHED | Active or certified unfinished drug listing | 2026-09-14 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | 27f29a85d7e4… | 1372111e901f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020504-001 | MICROZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020504-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020504-001 | MICROZIDE | 12.5MG | CAPSULE / ORAL | AB | RLD, RS | 1996-12-27 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020504-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020504-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020504-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020504-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020504-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020504-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020504-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020504-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020504-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020504-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020504-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020504-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020504-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020504-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020504-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020504-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020504-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020504-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020504-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020504-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020504-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020504-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020504-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020504-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020504-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020504-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020504-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020504-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020504-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020504-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020504-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020504-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020504-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020504-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020504-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020504-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020504-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020504-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020504-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020504-001 | AB | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrochlorothiazide
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0591-0347-01 | Hydrochlorothiazide | 100 in 1 BOTTLE | CAPSULE, GELATIN COATED | 100 | 24 | |
| 0591-0347-05 | Hydrochlorothiazide | 500 in 1 BOTTLE | CAPSULE, GELATIN COATED | 500 | 24 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0591-0347-01 | EA - Each | 0591-0347 | c9282ce9-22fd-4fa7-81cf-de180d8770f4 | 1 | 2012-07-24 |
| 0591-0347-05 | EA - Each | 0591-0347 | 1a2d2b20-68f7-4659-b5bf-f697687ef4db | 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 |
|---|---|---|---|---|---|---|
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | QPharma, Inc. | 5bacc909-6b02-4815-85ef-55fd25b1b1f7 | 2025-12-05 | Warnings, Adverse reactions | 020504 NDA020504 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | c1052d38-fd75-40c2-a685-0e889009be0b | 2023-02-01 | Warnings, Adverse reactions | 020504 NDA020504 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 0f7a608d-748b-49a9-a4b3-b3fdcab53ce0 | 2017-12-21 | Warnings, Adverse reactions | 020504 NDA020504 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Status |
|---|---|---|---|---|
| 0591-0347-77 | 00591034777 | 28085 CAPSULE, GELATIN COATED in 1 CONTAINER (0591-0347-77) | 01-AUG-24 | Current |