rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: westminster pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler westminster pharmaceuticals, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-362
Product ID 69367-362_447c034b-bd46-2a37-e063-6394a90a4feb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207062
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69367362
Hyphenated Format 69367-362

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0369367359092 0369367359108
UNII
83MVU38M7Q

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 rosuvastatin calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA207062 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (69367-362-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69367-362-05)
  • 90 TABLET, FILM COATED in 1 BOTTLE (69367-362-09)
  • 30 TABLET, FILM COATED in 1 BOTTLE (69367-362-30)
source: ndc

Packages (4)

69367-362-01 100 TABLET, FILM COATED in 1 BOTTLE (69367-362-01) 69367-362-05 500 TABLET, FILM COATED in 1 BOTTLE (69367-362-05) 69367-362-09 90 TABLET, FILM COATED in 1 BOTTLE (69367-362-09) 69367-362-30 30 TABLET, FILM COATED in 1 BOTTLE (69367-362-30)

Ingredients (1)

rosuvastatin calcium (40 mg/1)

Linked Drug Pages (1)

Rosuvastatin Calcium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "447c034b-bd46-2a37-e063-6394a90a4feb", "openfda": {"upc": ["0369367359092", "0369367359108"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["02797697-300a-43db-92cf-9b78f08626be"], "manufacturer_name": ["Westminster Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69367-362-01)", "package_ndc": "69367-362-01", "marketing_start_date": "20241201"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69367-362-05)", "package_ndc": "69367-362-05", "marketing_start_date": "20241201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69367-362-09)", "package_ndc": "69367-362-09", "marketing_start_date": "20241201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69367-362-30)", "package_ndc": "69367-362-30", "marketing_start_date": "20241201"}], "brand_name": "Rosuvastatin Calcium", "product_id": "69367-362_447c034b-bd46-2a37-e063-6394a90a4feb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69367-362", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Westminster Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA207062", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}