Package 82009-188-05

Brand: rosuvastatin

Generic: rosuvastatin
NDC Package

Package Facts

Identity

Package NDC 82009-188-05
Digits Only 8200918805
Product NDC 82009-188
Description

500 TABLET, FILM COATED in 1 BOTTLE (82009-188-05)

Marketing

Marketing Status
Marketed Since 2025-12-15
Brand rosuvastatin
Generic rosuvastatin
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0d12ae85-71bd-4818-a82d-fd068530bd87", "openfda": {"upc": ["0382009190051", "0382009191058"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["0d12ae85-71bd-4818-a82d-fd068530bd87"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-188-05)", "package_ndc": "82009-188-05", "marketing_start_date": "20251215"}], "brand_name": "Rosuvastatin", "product_id": "82009-188_0d12ae85-71bd-4818-a82d-fd068530bd87", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82009-188", "generic_name": "Rosuvastatin", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA206465", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20271231"}