rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: umedica laboratories usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler umedica laboratories usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
Umedica Laboratories USA Inc.

Identifiers & Regulatory

Product NDC 60290-046
Product ID 60290-046_4b2de301-734e-64eb-e063-6394a90a5b91
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207626
Listing Expiration 2027-12-31
Marketing Start 2025-11-30

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 60290046
Hyphenated Format 60290-046

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0360290045014 0360290043010 0360290046011 0360290044017
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 ANDA207626 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (60290-046-01)
  • 90 TABLET in 1 BOTTLE (60290-046-02)
  • 500 TABLET in 1 BOTTLE (60290-046-03)
  • 100 TABLET in 1 BLISTER PACK (60290-046-04)
  • 1000 TABLET in 1 BOTTLE (60290-046-05)
source: ndc

Packages (5)

60290-046-01 30 TABLET in 1 BOTTLE (60290-046-01) 60290-046-02 90 TABLET in 1 BOTTLE (60290-046-02) 60290-046-03 500 TABLET in 1 BOTTLE (60290-046-03) 60290-046-04 100 TABLET in 1 BLISTER PACK (60290-046-04) 60290-046-05 1000 TABLET in 1 BOTTLE (60290-046-05)

Ingredients (1)

rosuvastatin calcium (40 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": "4b2de301-734e-64eb-e063-6394a90a5b91", "openfda": {"upc": ["0360290045014", "0360290043010", "0360290046011", "0360290044017"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["989dffcf-0254-439d-9f3f-3b0e9d32de0a"], "manufacturer_name": ["Umedica Laboratories USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (60290-046-01)", "package_ndc": "60290-046-01", "marketing_start_date": "20251130"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (60290-046-02)", "package_ndc": "60290-046-02", "marketing_start_date": "20251130"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (60290-046-03)", "package_ndc": "60290-046-03", "marketing_start_date": "20251130"}, {"sample": false, "description": "100 TABLET in 1 BLISTER PACK (60290-046-04)", "package_ndc": "60290-046-04", "marketing_start_date": "20260215"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (60290-046-05)", "package_ndc": "60290-046-05", "marketing_start_date": "20251130"}], "brand_name": "Rosuvastatin Calcium", "product_id": "60290-046_4b2de301-734e-64eb-e063-6394a90a5b91", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "60290-046", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Umedica Laboratories USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA207626", "marketing_category": "ANDA", "marketing_start_date": "20251130", "listing_expiration_date": "20271231"}