rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: northstar rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler northstar rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
NorthStar Rx, LLC

Identifiers & Regulatory

Product NDC 72603-364
Product ID 72603-364_4687569b-7762-fb06-e063-6294a90aadc7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207626
Listing Expiration 2026-12-31
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 72603364
Hyphenated Format 72603-364

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0372603367034 0372603367041 0372603367010 0372603364026 0372603364019 0372603365016 0372603366020 0372603367027 0372603366013 0372603366037 0372603365023
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
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (72603-364-01)
  • 1000 TABLET in 1 BOTTLE (72603-364-02)
source: ndc

Packages (2)

72603-364-01 90 TABLET in 1 BOTTLE (72603-364-01) 72603-364-02 1000 TABLET in 1 BOTTLE (72603-364-02)

Ingredients (1)

rosuvastatin calcium (5 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": "4687569b-7762-fb06-e063-6294a90aadc7", "openfda": {"upc": ["0372603367034", "0372603367041", "0372603367010", "0372603364026", "0372603364019", "0372603365016", "0372603366020", "0372603367027", "0372603366013", "0372603366037", "0372603365023"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["c622757d-7370-438b-8c2d-ef444a4f31dd"], "manufacturer_name": ["NorthStar Rx, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72603-364-01)", "package_ndc": "72603-364-01", "marketing_start_date": "20251215"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72603-364-02)", "package_ndc": "72603-364-02", "marketing_start_date": "20251215"}], "brand_name": "Rosuvastatin Calcium", "product_id": "72603-364_4687569b-7762-fb06-e063-6294a90aadc7", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72603-364", "generic_name": "Rosuvastatin Calcium", "labeler_name": "NorthStar Rx, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA207626", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}