losartan potassium and hydrochlorothiazide
- Product NDC
- 71610-671
- 11-digit product format
- 716100671
- Labeler code
- 71610
- Product ID
- 71610-671_2d778122-9382-4e15-a927-d652112b3606
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- losartan potassium and hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA204832
- Marketing category
- ANDA
- Marketing start
- 2017-07-21
- 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 | 0J48LPH2TH, 3ST302B24A |
| Rxcui | 979471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71610-671-30 | losartan potassium and hydrochlorothiazide | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 1 |
| 71610-671-45 | losartan potassium and hydrochlorothiazide | 45 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 45 | | 1 |
| 71610-671-53 | losartan potassium and hydrochlorothiazide | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
| 71610-671-60 | losartan potassium and hydrochlorothiazide | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 1 |
| 71610-671-70 | losartan potassium and hydrochlorothiazide | 120 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 120 | | 1 |
| 71610-671-80 | losartan potassium and hydrochlorothiazide | 180 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 180 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71610-671 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Current NDC, Legacy NDC, 6 package rows | 20221104_35099fd1-1bc9-428b-9b9c-71f574cc4156.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 |
|---|
| 71610-671-30 | 71610067130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-30) | 2022-11-02 | 0000-00-00 | No | No | Current |
| 71610-671-45 | 71610067145 | 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-45) | 2022-11-02 | 0000-00-00 | No | No | Current |
| 71610-671-53 | 71610067153 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-53) | 2022-11-03 | 0000-00-00 | No | No | Current |
| 71610-671-60 | 71610067160 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-60) | 2022-11-02 | 0000-00-00 | No | No | Current |
| 71610-671-70 | 71610067170 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-70) | 2022-11-02 | 0000-00-00 | No | No | Current |
| 71610-671-80 | 71610067180 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-671-80) | 2022-11-02 | 0000-00-00 | No | No | Current |