Hydrochlorothiazide
- Product NDC
- 68071-3323
- 11-digit product format
- 680713323
- Labeler code
- 68071
- Product ID
- 68071-3323_1cd709d4-ae48-e5f8-e063-6294a90a07ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA202556
- Marketing category
- ANDA
- Marketing start
- 2013-04-10
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH |
| Rxcui | 197770 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-3323-3 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-5 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-6 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-9 | 2024-07-09 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-6 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-9 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-3 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-5 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-6 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-9 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-6 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
| 68071-3323-9 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4fee-a910-e053-dadaa90a0b85 | HYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3323-3 | Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 5 |
| 68071-3323-5 | Hydrochlorothiazide | 15 in 1 BOTTLE | TABLET | 15 | | 5 |
| 68071-3323-6 | Hydrochlorothiazide | 60 in 1 BOTTLE | TABLET | 60 | | 5 |
| 68071-3323-9 | Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3323 | HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS, INC.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240711_53fe1730-a803-26b2-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-3323-3 | 68071332303 | 30 TABLET in 1 BOTTLE (68071-3323-3) | 30 tablet | 2017-07-10 | 0000-00-00 | No | No | Current |
| 68071-3323-5 | 68071332305 | 15 TABLET in 1 BOTTLE (68071-3323-5) | 15 tablet | 2017-07-10 | 0000-00-00 | No | No | Current |
| 68071-3323-6 | 68071332306 | 60 TABLET in 1 BOTTLE (68071-3323-6) | 60 tablet | 2017-07-10 | 0000-00-00 | No | No | Current |
| 68071-3323-9 | 68071332309 | 90 TABLET in 1 BOTTLE (68071-3323-9) | 90 tablet | 2017-07-10 | 0000-00-00 | No | No | Current |