losartan potassium (68382-137)

Drug Facts

Product Profile

Brand Name losartan potassium

Generic Name losartan potassium

Labeler zydus pharmaceuticals usa inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

losartan potassium 100 mg/1

Manufacturer

Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-137

Product ID 68382-137_0a4867c6-b625-44bf-ad89-79eaf2e490df

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA078243

Listing Expiration 2027-12-31

Marketing Start 2010-10-04

Pharmacologic Class

Classes

angiotensin 2 receptor antagonists [moa] angiotensin 2 receptor blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382137

Hyphenated Format 68382-137

Supplemental Identifiers

RxCUI

979480 979485 979492

UNII

3ST302B24A

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name losartan potassium (source: ndc)

Generic Name losartan potassium (source: ndc)

Application Number ANDA078243 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (68382-137-01)
30 TABLET, FILM COATED in 1 BOTTLE (68382-137-06)
1000 TABLET, FILM COATED in 1 BOTTLE (68382-137-10)
90 TABLET, FILM COATED in 1 BOTTLE (68382-137-16)
10 BLISTER PACK in 1 CARTON (68382-137-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-137-30)

source: ndc

Packages (5)

68382-137-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-137-01) 68382-137-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-137-06) 68382-137-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-137-10) 68382-137-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-137-16) 68382-137-77 10 BLISTER PACK in 1 CARTON (68382-137-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-137-30)

Ingredients (1)

losartan potassium (100 mg/1)

Linked Drug Pages (1)

Losartan Potassium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "0a4867c6-b625-44bf-ad89-79eaf2e490df", "openfda": {"unii": ["3ST302B24A"], "rxcui": ["979480", "979485", "979492"], "spl_set_id": ["3233c707-70b6-4c29-8210-913eeb2a38ed"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68382-137-01)", "package_ndc": "68382-137-01", "marketing_start_date": "20101004"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-137-06)", "package_ndc": "68382-137-06", "marketing_start_date": "20101004"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-137-10)", "package_ndc": "68382-137-10", "marketing_start_date": "20101004"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-137-16)", "package_ndc": "68382-137-16", "marketing_start_date": "20101004"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-137-77)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-137-30)", "package_ndc": "68382-137-77", "marketing_start_date": "20101004"}], "brand_name": "Losartan Potassium", "product_id": "68382-137_0a4867c6-b625-44bf-ad89-79eaf2e490df", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68382-137", "generic_name": "Losartan Potassium", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Losartan Potassium", "active_ingredients": [{"name": "LOSARTAN POTASSIUM", "strength": "100 mg/1"}], "application_number": "ANDA078243", "marketing_category": "ANDA", "marketing_start_date": "20101004", "listing_expiration_date": "20271231"}