Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 68788-8632
- 11-digit product format
- 687888632
- Labeler code
- 68788
- Product ID
- 68788-8632_d9eb22c4-2890-4b5e-bee1-b7f5a8f50dd3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078245
- Marketing category
- ANDA
- Marketing start
- 2024-04-15
- Substance
- HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
- Active strength
- 12.5; 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCHLOROTHIAZIDE | 12.5 mg/1 |
| LOSARTAN POTASSIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 3ST302B24A |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8632-1 | Losartan Potassium and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 2 |
| 68788-8632-3 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 2 |
| 68788-8632-6 | Losartan Potassium and Hydrochlorothiazide | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
| 68788-8632-9 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8632 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 4 package rows | 20240420_6eab1c0a-9328-42a6-8eae-d4e105c54716.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8632-1 | 68788863201 | 100 TABLET in 1 BOTTLE (68788-8632-1) | 100 tablet | 2024-04-15 | No | No | Historical |
| 68788-8632-3 | 68788863203 | 30 TABLET in 1 BOTTLE (68788-8632-3) | 30 tablet | 2024-04-15 | No | No | Historical |
| 68788-8632-6 | 68788863206 | 60 TABLET in 1 BOTTLE (68788-8632-6) | 60 tablet | 2024-04-15 | No | No | Historical |
| 68788-8632-9 | 68788863209 | 90 TABLET in 1 BOTTLE (68788-8632-9) | 90 tablet | 2024-04-15 | No | No | Historical |