Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 70518-3420
- 11-digit product format
- 705183420
- Labeler code
- 70518
- Product ID
- 70518-3420_4f0bfa27-7a0b-4faf-e063-6294a90a730a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- losartan potassium and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA204901
- Marketing category
- ANDA
- Marketing start
- 2022-05-16
- 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
- 2027-12-31
- 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 | 25 mg/1 |
| LOSARTAN POTASSIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 3ST302B24A |
| Rxcui | 979471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3420-0 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOX | TABLET, FILM COATED | 30 | | 10 |
| 70518-3420-1 | Losartan Potassium and Hydrochlorothiazide | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 10 |
| 70518-3420-2 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 10 |
| 70518-3420-3 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 10 |
| 70518-3420-4 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3420 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 7 | Current NDC, Legacy NDC, 5 package rows | 20240709_446e6998-01f6-4de0-be57-7fecf5448e95.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 |
|---|
| 70518-3420-0 | 70518342000 | 30 POUCH in 1 BOX (70518-3420-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-3420-1) | 30 pouch | 2022-05-16 | 0000-00-00 | No | No | Current |
| 70518-3420-1 | 70518342001 | 1 in 1 POUCH | | | | | | Historical |
| 70518-3420-2 | 70518342002 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3420-2) | | 2022-08-11 | 0000-00-00 | No | No | Current |
| 70518-3420-3 | 70518342003 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3420-3) | | 2022-12-13 | 0000-00-00 | No | No | Current |
| 70518-3420-4 | 70518342004 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3420-4) | | 2025-09-13 | | No | No | Historical |