Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 46708-450
- 11-digit product format
- 467080450
- Labeler code
- 46708
- Product ID
- 46708-450_d80ae5dd-3bdc-40a4-9589-dfb7f8eabe6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA091617
- Marketing category
- ANDA
- Marketing start
- 2016-05-23
- 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 |
|---|
| 46708-450-10 | Losartan Potassium and Hydrochlorothiazide | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 4 |
| 46708-450-10 | Losartan Potassium and Hydrochlorothiazide | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 4 |
| 46708-450-30 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 46708-450-90 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
| 46708-450-91 | Losartan Potassium and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-450 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 3 | Current NDC, Legacy NDC, 5 package rows | 20230126_bbf7e20d-dfc2-4115-8788-c0cac15a1148.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 |
|---|
| 46708-450-10 | 46708045010 | 100 BLISTER PACK in 1 CARTON (46708-450-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2016-05-23 | 0000-00-00 | No | No | Current |
| 46708-450-30 | 46708045030 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-450-30) | | 2016-05-23 | 0000-00-00 | No | No | Current |
| 46708-450-90 | 46708045090 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-450-90) | | 2016-05-23 | 0000-00-00 | No | No | Current |
| 46708-450-91 | 46708045091 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-450-91) | | 2016-05-23 | 0000-00-00 | No | No | Current |