losartan potassium

Generic: losartan potassium

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

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 25 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-135
Product ID 68382-135_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 68382135
Hyphenated Format 68382-135

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
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68382-135-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68382-135-06)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68382-135-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68382-135-16)
  • 10000 TABLET, FILM COATED in 1 BOTTLE (68382-135-24)
source: ndc

Packages (5)

68382-135-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-135-01) 68382-135-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-135-06) 68382-135-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-135-10) 68382-135-16 90 TABLET, FILM COATED in 1 BOTTLE (68382-135-16) 68382-135-24 10000 TABLET, FILM COATED in 1 BOTTLE (68382-135-24)

Ingredients (1)

losartan potassium (25 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 (68382-135-01)", "package_ndc": "68382-135-01", "marketing_start_date": "20101004"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68382-135-06)", "package_ndc": "68382-135-06", "marketing_start_date": "20101004"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68382-135-10)", "package_ndc": "68382-135-10", "marketing_start_date": "20101004"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68382-135-16)", "package_ndc": "68382-135-16", "marketing_start_date": "20101004"}, {"sample": false, "description": "10000 TABLET, FILM COATED in 1 BOTTLE (68382-135-24)", "package_ndc": "68382-135-24", "marketing_start_date": "20101004"}], "brand_name": "Losartan Potassium", "product_id": "68382-135_0a4867c6-b625-44bf-ad89-79eaf2e490df", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "68382-135", "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": "25 mg/1"}], "application_number": "ANDA078243", "marketing_category": "ANDA", "marketing_start_date": "20101004", "listing_expiration_date": "20271231"}