Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 68180-215
- 11-digit product format
- 681800215
- Labeler code
- 68180
- Product ID
- 68180-215_6b0e9bc3-30a9-47ce-8cbe-c51404d51ae6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA078245
- Marketing category
- ANDA
- Marketing start
- 2010-10-06
- 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 | 979464, 979468, 979471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68180-215-01 | Losartan Potassium and Hydrochlorothiazide | 100 in 1 BOTTLE | TABLET | 100 | | 22 |
| 68180-215-03 | Losartan Potassium and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET | 1000 | | 22 |
| 68180-215-06 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET | 30 | | 22 |
| 68180-215-09 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET | 90 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| LOSARTAN POTASSIUM | ACTIVE INGREDIENT | 3ST302B24A | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| LOSARTAN | ACTIVE MOIETY | JMS50MPO89 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| STARCH, PREGELATINIZED CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68180-215 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET [LUPIN PHARMACEUTICALS, INC.] | 20 | Current NDC, Legacy NDC, 4 package rows | 20250513_ee1eaaf6-050b-48af-942b-5e3451edc164.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 |
|---|
| 68180-215-01 | 68180021501 | 100 TABLET in 1 BOTTLE (68180-215-01) | 100 tablet | 2010-10-06 | 0000-00-00 | No | No | Current |
| 68180-215-03 | 68180021503 | 1000 TABLET in 1 BOTTLE (68180-215-03) | 1000 tablet | 2010-10-06 | 0000-00-00 | No | No | Current |
| 68180-215-06 | 68180021506 | 30 TABLET in 1 BOTTLE (68180-215-06) | 30 tablet | 2010-10-06 | 0000-00-00 | No | No | Current |
| 68180-215-09 | 68180021509 | 90 TABLET in 1 BOTTLE (68180-215-09) | 90 tablet | 2010-10-06 | 0000-00-00 | No | No | Current |