Hydrochlorothiazide
- Product NDC
- 58118-0123
- Requested package NDC
- 58118-0123-8
- 11-digit product format
- 581180123
- Labeler code
- 58118
- Product ID
- 58118-0123_adc8df0b-6ce0-550d-e053-2995a90a19b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Clinical Solutions Wholesale, LLC
- Application
- ANDA040907
- Marketing category
- ANDA
- Marketing start
- 2009-07-02
- 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
- 2021-12-31
- 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 package | package | 58118-0123 | 58118-0123-8 | 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 |
|---|---|---|---|---|---|---|---|
| A040907-001 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2008-08-15 | |
| A040907-002 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2008-08-15 | |
| A040907-003 | HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | 2025-04-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040907-001 | AB |
| A040907-002 | AB |
| A040907-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A040907-001 | HYDROCHLOROTHIAZIDE | 25MG | TABLET / ORAL | AB | 2008-08-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A040907-002 | HYDROCHLOROTHIAZIDE | 50MG | TABLET / ORAL | AB | 2008-08-15 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A040907-003 | HYDROCHLOROTHIAZIDE | 12.5MG | TABLET / ORAL | AB | 2025-04-03 | 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 | A040907-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040907-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A040907-003 | 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 | Unit Dose Solutions, Inc. | 54f027ea-0a6e-7920-e063-6394a90ab6ae | 2026-06-23 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | St. Mary's Medical Park Pharmacy | 8a1de4e2-3aca-a4d3-e053-2995a90a1a41 | 2026-06-17 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Preferred Pharmaceuticals Inc. | 99f45e08-897d-44dd-b48d-aa6d78981f0c | 2026-05-11 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | REMEDYREPACK INC. | 2fd8f595-7aec-4308-bb17-a6f2e7190044 | 2026-04-15 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Coupler LLC | 4ee35bcf-1eb0-1cca-e063-6294a90adeed | 2026-04-07 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | American Health Packaging | 2ec371a5-18ba-4ce2-9725-7f99bb73454a | 2026-03-05 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e | 2026-02-06 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | 088cb67f-3eaa-4e78-9fbe-ad2d6b7c5707 | 2026-02-06 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | A-S Medication Solutions | f1f99065-04d2-48ac-b25d-9595237c869c | 2026-02-06 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Northwind Health Company, LLC | f2f3b60a-bffe-2675-e053-2995a90ae96e | 2026-01-01 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | QPharma, Inc. | 9cd5d16e-3db7-4b25-847d-6de91543463b | 2025-12-15 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | PD-Rx Pharmaceuticals, Inc. | 67bedecc-f758-4bc6-82c5-7d428cbbbd9b | 2025-08-22 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | d7d0867a-748e-4960-851f-ad764e07f774 | 2025-08-20 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Bryant Ranch Prepack | 73bc116a-2964-4acc-9ef0-0a3f66268913 | 2025-07-14 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Unichem Pharmaceuticals (USA), Inc. | 33f3b980-b339-4dbf-99bd-05588c2a298c | 2025-06-13 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Redpharm drug | fa1c0b92-4360-bcfd-e053-6394a90a955a | 2025-01-23 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Direct_Rx | 05156717-fe1b-22f1-e063-6394a90a3d10 | 2025-01-22 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Lake Erie Medical DBA Quality Care Products LLC | 9e6a0c83-1494-44ca-90e0-3f43fa8ec746 | 2024-12-16 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | NuCare Pharmaceuticals,Inc. | 8bc8d5e2-a974-64ed-e053-2a95a90a8340 | 2024-09-05 | Warnings, Adverse reactions | 040907 ANDA040907 |
| Hydrochlorothiazide | HYDROCHLOROTHIAZIDE | Proficient Rx LP | ff448eb4-b48f-46f5-ac30-f03aad08f9f5 | 2024-03-01 | Warnings, Adverse reactions | 040907 ANDA040907 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58118-0123-8 | 2024-01-30 | C162847 | 48780-1 | 1030e365-45e6-111a-e063-dadaa90a10e2 | Hydrochlorothiazide Tablets USP |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-0123 | HYDROCHLOROTHIAZIDE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC] | 7 | Legacy NDC | 20200827_5451596e-823d-4aaf-96f6-470f034b5f94.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58118-0123-8 | 58118012308 | 30 TABLET in 1 BLISTER PACK (58118-0123-8) | 30 tablet | 2016-06-28 | 0000-00-00 | No | No | Current |