rosuvastatin calcium (69367-361)

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 20 mg/1

Manufacturer

Westminster Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 69367-361

Product ID 69367-361_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 69367361

Hyphenated Format 69367-361

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

20 mg/1

source: ndc

Packaging

100 TABLET, FILM COATED in 1 BOTTLE (69367-361-01)
500 TABLET, FILM COATED in 1 BOTTLE (69367-361-05)
90 TABLET, FILM COATED in 1 BOTTLE (69367-361-09)
1000 TABLET, FILM COATED in 1 BOTTLE (69367-361-10)
30 TABLET, FILM COATED in 1 BOTTLE (69367-361-30)

source: ndc

Packages (5)

69367-361-01 100 TABLET, FILM COATED in 1 BOTTLE (69367-361-01) 69367-361-05 500 TABLET, FILM COATED in 1 BOTTLE (69367-361-05) 69367-361-09 90 TABLET, FILM COATED in 1 BOTTLE (69367-361-09) 69367-361-10 1000 TABLET, FILM COATED in 1 BOTTLE (69367-361-10) 69367-361-30 30 TABLET, FILM COATED in 1 BOTTLE (69367-361-30)

Ingredients (1)

rosuvastatin calcium (20 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 (69367-361-01)", "package_ndc": "69367-361-01", "marketing_start_date": "20241201"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69367-361-05)", "package_ndc": "69367-361-05", "marketing_start_date": "20241201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69367-361-09)", "package_ndc": "69367-361-09", "marketing_start_date": "20241201"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69367-361-10)", "package_ndc": "69367-361-10", "marketing_start_date": "20241201"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69367-361-30)", "package_ndc": "69367-361-30", "marketing_start_date": "20241201"}], "brand_name": "Rosuvastatin Calcium", "product_id": "69367-361_447c034b-bd46-2a37-e063-6394a90a4feb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "69367-361", "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": "20 mg/1"}], "application_number": "ANDA207062", "marketing_category": "ANDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}