Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 70518-3398
- 11-digit product format
- 705183398
- Labeler code
- 70518
- Product ID
- 70518-3398_4ef5ba03-0842-b01a-e063-6294a90a489d
- 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
- 2022-03-30
- 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
- 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 | 12.5 mg/1 |
| LOSARTAN POTASSIUM | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0J48LPH2TH, 3ST302B24A |
| Rxcui | 979464 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3398-0 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 6 |
| 70518-3398-1 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 6 |
| 70518-3398-2 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3398 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [REMEDYREPACK INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20241004_fd07d24c-6db1-4f6b-b226-68abba3a3321.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 |
|---|
| 70518-3398-0 | 70518339800 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3398-0) | 2022-03-30 | 0000-00-00 | No | No | Current |
| 70518-3398-1 | 70518339801 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3398-1) | 2022-08-30 | | No | No | Current |
| 70518-3398-2 | 70518339802 | 30 in 1 BLISTER PACK | | | | | Historical |