rosuvastatin

Generic: rosuvastatin

Labeler: quallent pharmaceuticals health llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rosuvastatin calcium 40 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-191
Product ID 82009-191_0d12ae85-71bd-4818-a82d-fd068530bd87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206465
Listing Expiration 2027-12-31
Marketing Start 2025-12-15

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 82009191
Hyphenated Format 82009-191

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0382009190051 0382009191058
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 (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number ANDA206465 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (82009-191-05)
source: ndc

Packages (1)

82009-191-05 500 TABLET, FILM COATED in 1 BOTTLE (82009-191-05)

Ingredients (1)

rosuvastatin calcium (40 mg/1)

Linked Drug Pages (1)

Rosuvastatin ndc-match (0.9)

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 (82009-191-05)", "package_ndc": "82009-191-05", "marketing_start_date": "20251215"}], "brand_name": "Rosuvastatin", "product_id": "82009-191_0d12ae85-71bd-4818-a82d-fd068530bd87", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82009-191", "generic_name": "Rosuvastatin", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA206465", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20271231"}