Application 011835
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | HYDRODIURIL | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 006 | HYDRODIURIL | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | HYDRODIURIL | HYDROCHLOROTHIAZIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011835-003 | HYDRODIURIL | HYDROCHLOROTHIAZIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011835-006 | HYDRODIURIL | HYDROCHLOROTHIAZIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N011835-007 | HYDRODIURIL | HYDROCHLOROTHIAZIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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| 2026-08 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011835-006 | HYDRODIURIL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011835-007 | HYDRODIURIL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011835-003 | HYDRODIURIL | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… |
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 | Alembic Pharmaceuticals Limited | 34703033-14c4-459c-8b8f-2f2e1145aff7 | 2023-01-30 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | 98edae8a-99dc-4f26-a956-3ad58bf38a26 | 2022-06-01 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | 48b4d633-ecfa-4748-80e8-6c0e3d8b067e | 2022-05-02 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | fd9b3e5a-f564-4730-8b9f-2cdc2953cbc9 | 2022-04-01 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | b54ec2b1-3325-46a1-b654-8a75dc41ab0a | 2022-03-01 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 4c3403a6-da6a-4f37-bc7e-9fe0aa284305 | 2021-12-07 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | f0b993f2-9771-42e3-b10e-09719189e2bd | 2021-01-19 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | 6be05675-c4b4-4e1e-9047-044a7fc7cef6 | 2021-01-01 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | 78c04f59-65c3-4a16-83a6-ed4a409afce5 | 2021-01-01 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | e8ca7334-4b58-4f4b-bf36-0ab47b60ff7c | 2020-12-14 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | ec70ea28-a219-45d1-9d5b-6a79c7ef4987 | 2020-10-28 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Alembic Pharmaceuticals Inc. | 841b7962-bf5d-4c45-b594-80b17ba5187d | 2020-09-11 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 0fdb6713-8013-4cfe-a776-0c1e9414a91c | 2020-06-02 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Solco Healthcare U.S., LLC | 60c97ab9-b25e-4ea5-a159-792292178c65 | 2020-05-20 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | ScieGen Pharmaceuticals, Inc. | 02e96a51-1d56-460c-8c20-3d6f37e0ce46 | 2020-05-11 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Exelan Pharmaceuticals Inc. | b5a1b38c-0433-4649-a8b0-f72db0a96c45 | 2018-12-28 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 0f7a608d-748b-49a9-a4b3-b3fdcab53ce0 | 2017-12-21 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 61487122-8a94-4ad5-a307-7893e0b7510c | 2017-10-13 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 2febae4f-836e-4935-bd06-3495f87b3b82 | 2017-08-15 | Warnings, Adverse reactions | HYDROCHLOROTHIAZIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.