Hydrochlorothiazide
- Product NDC
- 43547-398
- 11-digit product format
- 435470398
- Labeler code
- 43547
- Product ID
- 43547-398_d8ce29b2-7f3a-4944-bf9e-0fcebb25d3c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Solco Healthcare U.S., LLC
- Application
- ANDA040412
- Marketing category
- ANDA
- Marketing start
- 2002-03-29
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040412-001 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | ||
| A040412-002 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 |
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 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | 2002-03-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | 2002-03-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040412-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2002-03-29 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040412-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2002-03-29 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040412-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040412-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040412-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040412-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040412-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040412-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040412-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040412-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040412-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040412-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040412-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040412-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040412-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040412-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040412-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040412-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040412-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040412-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040412-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040412-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040412-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040412-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040412-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A040412-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040412-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A040412-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040412-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A040412-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040412-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A040412-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040412-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040412-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040412-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040412-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040412-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040412-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040412-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A040412-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040412-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A040412-002 | AB | 1 | ea1830bbd6c7… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HYDROCHLOROTHIAZIDE | 50 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0J48LPH2TH | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 60c97ab9-b25e-4ea5-a159-792292178c65 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43547-398-01 | Hydrochlorothiazide | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | 2 | |
| 43547-398-03 | Hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 2 | |
| 43547-398-05 | Hydrochlorothiazide | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 2 | |
| 43547-398-10 | Hydrochlorothiazide | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 2 | |
| 43547-398-11 | Hydrochlorothiazide | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | 2 | |
| 43547-398-50 | Hydrochlorothiazide | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43547-398-10 | EA - Each | 43547-398 | c96b89be-b3fb-4fb1-9c6e-4962e14be4d3 | 1 | 2017-05-03 |
| 43547-398-11 | EA - Each | 43547-398 | 5ea3eb5e-c4df-4a4c-ae30-864de26c9321 | 1 | 2017-05-03 |
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 | American Health Packaging | c8de63da-b6c0-42f0-9d47-e273fe93adb3 | 2026-04-07 | Warnings, Adverse reactions | 040412 ANDA040412 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 5f2e72cc-073d-4bb5-95fe-53d4060127ec | 2024-12-05 | Warnings, Adverse reactions | 040412 ANDA040412 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 78d65a02-c78e-4f98-b756-3cb5ee78f252 | 2024-02-20 | Warnings, Adverse reactions | 040412 ANDA040412 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 24cba606-263f-46dc-a4dc-fddc729c0f4b | 2023-10-18 | Warnings, Adverse reactions | 040412 ANDA040412 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 4c3403a6-da6a-4f37-bc7e-9fe0aa284305 | 2021-12-07 | Warnings, Adverse reactions | 040412 ANDA040412 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 0fdb6713-8013-4cfe-a776-0c1e9414a91c | 2020-06-02 | Warnings, Adverse reactions | 040412 ANDA040412 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Solco Healthcare U.S., LLC | 60c97ab9-b25e-4ea5-a159-792292178c65 | 2020-05-20 | Warnings, Adverse reactions | 040412 ANDA040412 43547-398 |
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43547-398-01 | 43547039801 | 10 TABLET in 1 BOTTLE, PLASTIC (43547-398-01) | 10 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-03 | 43547039803 | 30 TABLET in 1 BOTTLE, PLASTIC (43547-398-03) | 30 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-05 | 43547039805 | 50 TABLET in 1 BOTTLE, PLASTIC (43547-398-05) | 50 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-10 | 43547039810 | 100 TABLET in 1 BOTTLE, PLASTIC (43547-398-10) | 100 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-11 | 43547039811 | 1000 TABLET in 1 BOTTLE, PLASTIC (43547-398-11) | 1000 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |
| 43547-398-50 | 43547039850 | 500 TABLET in 1 BOTTLE, PLASTIC (43547-398-50) | 500 tablet | 2002-03-29 | 0000-00-00 | No | No | Current |