Losartan Potassium and Hydrochlorothiazide
- Product NDC
- 16714-226
- 11-digit product format
- 167140226
- Labeler code
- 16714
- Product ID
- 16714-226_d3aeeeca-2c3a-4006-89f7-e3836aa8399b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Losartan Potassium and Hydrochlorothiazide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA091629
- Marketing category
- ANDA
- Marketing start
- 2024-09-04
- 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 | 3ST302B24A, 0J48LPH2TH |
| Rxcui | 979464, 979468, 979471 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16714-226-01 | Losartan Potassium and Hydrochlorothiazide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 21 |
| 16714-226-02 | Losartan Potassium and Hydrochlorothiazide | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 21 |
| 16714-226-04 | Losartan Potassium and Hydrochlorothiazide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 21 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| HYDROCHLOROTHIAZIDE | ACTIVE INGREDIENT | 0J48LPH2TH | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| LOSARTAN POTASSIUM | ACTIVE INGREDIENT | 3ST302B24A | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| HYDROCHLOROTHIAZIDE | ACTIVE MOIETY | 0J48LPH2TH | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| LOSARTAN | ACTIVE MOIETY | JMS50MPO89 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 10 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-226 | LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [NORTHSTAR RX LLC] | 20 | Current NDC, Legacy NDC, 3 package rows | 20240906_25318baf-9c2f-458f-b9ea-f52dabca49af.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 |
|---|
| 16714-226-01 | 16714022601 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-226-01) | | 2024-09-04 | 2022-07-31 | No | No | Current |
| 16714-226-02 | 16714022602 | 90 TABLET, FILM COATED in 1 BOTTLE (16714-226-02) | | 2024-09-04 | 2022-07-31 | No | No | Current |
| 16714-226-04 | 16714022604 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-226-04) | | 2024-09-04 | 2022-07-31 | No | No | Current |
| 16714-226-06 | 16714022606 | 10 BLISTER PACK in 1 CARTON (16714-226-06) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2010-10-06 | 2022-07-31 | No | No | Current |