Hydrochlorothiazide
- Product NDC
- 70934-930
- 11-digit product format
- 709340930
- Labeler code
- 70934
- Product ID
- 70934-930_d1f0ed23-fdb2-5295-e053-2a95a90ae9e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA203561
- Marketing category
- ANDA
- Marketing start
- 2021-11-24
- Marketing end
- 0000-00-00
- Substance
- HYDROCHLOROTHIAZIDE
- Active strength
- 13 mg/1
- Pharmacologic classes
- Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70934-930 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 70934-930 | 70934-930-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 70934-930 | 70934-930-90 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203561-001 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE / ORAL | AB | 2019-01-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203561-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A203561-001 | HYDROCHLOROTHIAZIDE | 12.5MG | CAPSULE / ORAL | AB | 2019-01-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A203561-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 0789baef-3424-43ab-a3fb-4908172da565 | 2026-07-24 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | cb7b7315-0170-492c-803f-60a6e75e55da | 2026-07-08 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 2b21f3fc-4164-401a-803e-b982dea97e19 | 2026-05-14 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals, Inc. | 918391e3-e8b3-4ceb-b4e7-c7c9617ea882 | 2026-05-11 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | ff557069-f177-4e2e-91f4-675a033e2739 | 2026-04-14 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 45316037-52ec-438f-8780-b2e983fef3f5 | 2026-03-31 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Westminster Pharmaceuticals, LLC | 0fc94bc2-fa38-439a-a609-1b4130cdacb1 | 2026-03-17 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | ScieGen Pharmaceuticals Inc | 911a18c1-120a-46b3-b7a8-25eb37843473 | 2026-02-10 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | AvPAK | ef56450d-86d3-2654-e053-2995a90a142c | 2026-01-08 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f32ce8fe-6cbc-8a15-e053-2995a90a8eec | 2026-01-01 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 02a481cb-ad80-41bb-82d3-c237b00ed8d7 | 2025-05-15 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | bd5728a2-6322-42e3-bd1e-e4915750e398 | 2023-12-28 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | NCS HealthCare of KY, LLC dba Vangard Labs | d6b933c6-f5f8-406a-84d6-b22c6040482a | 2023-10-19 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | 460f922c-1fda-44a5-889e-d7009883176b | 2023-05-01 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | 69c41abb-75f4-429b-905a-1ce967924aee | 2023-04-04 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | b54ec2b1-3325-46a1-b654-8a75dc41ab0a | 2022-03-01 | Warnings, Adverse reactions | 203561 ANDA203561 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Aphena Pharma Solutions - Tennessee, LLC | f0b993f2-9771-42e3-b10e-09719189e2bd | 2021-01-19 | Warnings, Adverse reactions | 203561 ANDA203561 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-930-30 | 70934093030 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70934-930-30) | 30 capsule | 2021-11-24 | 0000-00-00 | No | No | Current |
| 70934-930-90 | 70934093090 | 90 CAPSULE in 1 BOTTLE, PLASTIC (70934-930-90) | 90 capsule | 2021-11-24 | 0000-00-00 | No | No | Current |