Hydrochlorothiazide
- Product NDC
- 71335-1350
- Requested package NDC
- 71335-1350-1
- 11-digit product format
- 713351350
- Labeler code
- 71335
- Product ID
- 71335-1350_4a8910de-61c1-4a1d-952f-e35268f493e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA083177
- Marketing category
- ANDA
- Marketing start
- 1973-01-12
- Marketing end
- 0000-00-00
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|
| excluded package | package | 71335-1350 | 71335-1350-1 | D | Discontinued by firm | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083177-001 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A083177-002 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| A083177-003 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A083177-001 | AB |
| A083177-002 | AB |
| A083177-003 | 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 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | RLD | 2024-09-19 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | 2024-09-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A083177-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | 2024-09-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083177-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A083177-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5d02ea3f76ae… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A083177-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A083177-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A083177-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083177-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083177-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A083177-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A083177-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A083177-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A083177-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083177-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083177-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A083177-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083177-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083177-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A083177-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083177-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083177-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A083177-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083177-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083177-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A083177-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083177-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A083177-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083177-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083177-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A083177-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A083177-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A083177-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A083177-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083177-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A083177-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083177-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A083177-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083177-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A083177-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A083177-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A083177-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083177-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A083177-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A083177-001 | AB | 1 | 5d02ea3f76ae… |
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 | Redpharm Drug | 57436cfa-9b94-89bf-e063-6394a90aa264 | 2026-07-23 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Legacy Pharmaceutical Packaging, LLC | 1d6ea4b4-1e3c-4f3f-989c-1a3a3c0da6bd | 2026-03-05 | Warnings | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f7091c54-0984-7f6e-e053-6394a90afb4d | 2026-01-01 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | QPharma, Inc. | c9c44c37-bb49-4364-9293-3c8fd51b759e | 2025-12-16 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 0937d511-4d5e-4aba-bfae-92094c67bcf4 | 2025-11-20 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | c182b6a9-1a31-45ee-9cea-a557c99f5db7 | 2025-11-20 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | ef8a7dee-3704-4c62-8981-f8adfb47f5d0 | 2025-11-20 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 8d5a9196-5f1d-2d83-e053-2a95a90a6036 | 2025-06-27 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 852c6f3f-d3f5-0d99-e053-2991aa0aa9c3 | 2025-02-21 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Teva Pharmaceuticals USA, Inc. | e2270db4-2930-4ec5-ac96-2b4542aed367 | 2024-07-01 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | b9e1bed7-fef9-434a-92f9-b70941176e3e | 2023-09-11 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | b56a3559-6eb2-4a8d-a9a4-232d2ff0febe | 2023-06-29 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | c4fe84e3-c291-4220-95c1-a2bd02b1e134 | 2023-02-01 | Warnings, Adverse reactions | 083177 ANDA083177 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 61487122-8a94-4ad5-a307-7893e0b7510c | 2017-10-13 | Warnings, Adverse reactions | 083177 ANDA083177 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71335-1350-1 | 71335135001 | 100 TABLET in 1 BOTTLE (71335-1350-1) | 100 tablet | 2022-06-29 | 0000-00-00 | No | No | Current |