Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 68071-4518
- 11-digit product format
- 680714518
- Labeler code
- 68071
- Product ID
- 68071-4518_1a90743b-5d6f-a8e1-e063-6394a90af6f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA077157
- Marketing category
- ANDA
- Marketing start
- 2010-04-06
- Substance
- HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
- Active strength
- 25; 100 mg/1; mg/1
- Pharmacologic classes
- Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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
- Losartan Potassium and Hydrochlorothiazide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 25 mg/1 |
| LOSARTAN POTASSIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 3ST302B24A |
| Rxcui | 979471 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4518-3 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
| 68071-4518-9 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4518 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240612_72c97b7f-d945-5106-e053-2a91aa0a9b3b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-4518-3 | 68071451803 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4518-3) | 2018-08-06 | 0000-00-00 | No | No | Current |
| 68071-4518-9 | 68071451809 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-4518-9) | 2018-08-06 | 0000-00-00 | No | No | Current |