losartan potassium

Generic: losartan potassium

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name losartan potassium
Generic Name losartan potassium
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

losartan potassium 25 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-445
Product ID 46708-445_cedeb352-a540-4778-84e6-304f898fe17f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090428
Listing Expiration 2026-12-31
Marketing Start 2016-05-23

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 46708445
Hyphenated Format 46708-445

Supplemental Identifiers

RxCUI
979480 979485 979492
UPC
0346708447304 0346708445300 0346708446307
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 ANDA090428 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-445-30)
  • 100 TABLET, FILM COATED in 1 BOTTLE (46708-445-31)
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-445-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-445-91)
source: ndc

Packages (4)

Ingredients (1)

losartan potassium (25 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "cedeb352-a540-4778-84e6-304f898fe17f", "openfda": {"upc": ["0346708447304", "0346708445300", "0346708446307"], "unii": ["3ST302B24A"], "rxcui": ["979480", "979485", "979492"], "spl_set_id": ["eeb77c84-38d3-432d-914a-54b312b374bd"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-445-30)", "package_ndc": "46708-445-30", "marketing_start_date": "20160523"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (46708-445-31)", "package_ndc": "46708-445-31", "marketing_start_date": "20160523"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-445-90)", "package_ndc": "46708-445-90", "marketing_start_date": "20160523"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-445-91)", "package_ndc": "46708-445-91", "marketing_start_date": "20160523"}], "brand_name": "Losartan Potassium", "product_id": "46708-445_cedeb352-a540-4778-84e6-304f898fe17f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]"], "product_ndc": "46708-445", "generic_name": "Losartan Potassium", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Losartan Potassium", "active_ingredients": [{"name": "LOSARTAN POTASSIUM", "strength": "25 mg/1"}], "application_number": "ANDA090428", "marketing_category": "ANDA", "marketing_start_date": "20160523", "listing_expiration_date": "20261231"}