rosuvastatin

Generic: rosuvastatin

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-711
Product ID 50268-711_39ff0f38-7c7a-4ce1-e063-6394a90aa663
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207616
Listing Expiration 2026-12-31
Marketing Start 2018-12-14

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 50268711
Hyphenated Format 50268-711

Supplemental Identifiers

RxCUI
859419 859747 859751
UNII
83MVU38M7Q

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 ANDA207616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-711-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-711-11)
source: ndc

Packages (1)

50268-711-15 50 BLISTER PACK in 1 BOX (50268-711-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-711-11)

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": "39ff0f38-7c7a-4ce1-e063-6394a90aa663", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419", "859747", "859751"], "spl_set_id": ["7cd6ae8d-aa67-60db-e053-2991aa0a0ede"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-711-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-711-11)", "package_ndc": "50268-711-15", "marketing_start_date": "20181214"}], "brand_name": "Rosuvastatin", "product_id": "50268-711_39ff0f38-7c7a-4ce1-e063-6394a90aa663", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "50268-711", "generic_name": "Rosuvastatin", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA207616", "marketing_category": "ANDA", "marketing_start_date": "20181214", "listing_expiration_date": "20261231"}