Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 68788-8187
- 11-digit product format
- 687888187
- Labeler code
- 68788
- Product ID
- 68788-8187_89e06172-44a8-4129-bda1-06c7505c9728
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- losartan potassium and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204901
- Marketing category
- ANDA
- Marketing start
- 2022-05-10
- Substance
- HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
- Active strength
- 12.5; 50 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 | 12.5 mg/1 |
| LOSARTAN POTASSIUM | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 3ST302B24A |
| Rxcui | 979468 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8187-1 | Losartan Potassium and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 4 |
| 68788-8187-3 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 68788-8187-6 | Losartan Potassium and Hydrochlorothiazide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
| 68788-8187-9 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8187 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240629_46cf633d-70a5-4d3b-b349-ad74c23ddace.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 |
|---|
| 68788-8187-1 | 68788818701 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8187-1) | 2022-05-10 | 0000-00-00 | No | No | Current |
| 68788-8187-3 | 68788818703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8187-3) | 2022-05-10 | 0000-00-00 | No | No | Current |
| 68788-8187-6 | 68788818706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8187-6) | 2022-05-10 | 0000-00-00 | No | No | Current |
| 68788-8187-9 | 68788818709 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8187-9) | 2022-05-10 | 0000-00-00 | No | No | Current |