Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 42291-504
- 11-digit product format
- 422910504
- Labeler code
- 42291
- Product ID
- 42291-504_3d743217-99d1-2bbc-e063-6294a90a6adf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- losartan potassium and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA201845
- Marketing category
- ANDA
- Marketing start
- 2022-08-31
- 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 | 3ST302B24A, 0J48LPH2TH |
| Rxcui | 979464, 979468, 979471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-504-10 | Losartan Potassium and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 42291-504-90 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-504 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [AVKARE] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250209_e78b2195-a2da-3d03-e053-2a95a90a7d56.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 |
|---|
| 42291-504-10 | 42291050410 | 1000 TABLET, FILM COATED in 1 BOTTLE (42291-504-10) | 2022-08-31 | | No | No | Current |
| 42291-504-90 | 42291050490 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-504-90) | 2022-08-31 | 0000-00-00 | No | No | Current |