rosuvastatin

Generic: rosuvastatin

Labeler: sciegen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler sciegen pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin 40 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-119
Product ID 50228-119_2fb0db87-33a8-e6a1-e063-6294a90a5b4a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206381
Listing Expiration 2026-12-31
Marketing Start 2019-04-24

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228119
Hyphenated Format 50228-119

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0350228118057 0350228117104 0350228118903 0350228116909 0350228119054 0350228119306 0350228118101 0350228117050 0350228117906 0350228116053 0350228116107 0350228119900
UNII
413KH5ZJ73
NUI
N0000175589 N0000000121

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 ANDA206381 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (50228-119-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (50228-119-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50228-119-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50228-119-90)
source: ndc

Packages (4)

50228-119-05 500 TABLET, FILM COATED in 1 BOTTLE (50228-119-05) 50228-119-10 1000 TABLET, FILM COATED in 1 BOTTLE (50228-119-10) 50228-119-30 30 TABLET, FILM COATED in 1 BOTTLE (50228-119-30) 50228-119-90 90 TABLET, FILM COATED in 1 BOTTLE (50228-119-90)

Ingredients (1)

rosuvastatin (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": "2fb0db87-33a8-e6a1-e063-6294a90a5b4a", "openfda": {"nui": ["N0000175589", "N0000000121"], "upc": ["0350228118057", "0350228117104", "0350228118903", "0350228116909", "0350228119054", "0350228119306", "0350228118101", "0350228117050", "0350228117906", "0350228116053", "0350228116107", "0350228119900"], "unii": ["413KH5ZJ73"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["ee4933c5-0d97-494d-ac0f-2083e0100836"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (50228-119-05)", "package_ndc": "50228-119-05", "marketing_start_date": "20230907"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (50228-119-10)", "package_ndc": "50228-119-10", "marketing_start_date": "20190424"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50228-119-30)", "package_ndc": "50228-119-30", "marketing_start_date": "20190424"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50228-119-90)", "package_ndc": "50228-119-90", "marketing_start_date": "20190424"}], "brand_name": "Rosuvastatin", "product_id": "50228-119_2fb0db87-33a8-e6a1-e063-6294a90a5b4a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "50228-119", "generic_name": "Rosuvastatin", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN", "strength": "40 mg/1"}], "application_number": "ANDA206381", "marketing_category": "ANDA", "marketing_start_date": "20190424", "listing_expiration_date": "20261231"}