rosuvastatin

Generic: rosuvastatin

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 10 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-0158
Product ID 55154-0158_9baad60e-b35a-46f7-905f-f731c056961c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207616
Listing Expiration 2027-12-31
Marketing Start 2025-07-14

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 551540158
Hyphenated Format 55154-0158

Supplemental Identifiers

RxCUI
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
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-0158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-0158-0 10 BLISTER PACK in 1 BAG (55154-0158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

rosuvastatin calcium (10 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": "9baad60e-b35a-46f7-905f-f731c056961c", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859747", "859751"], "spl_set_id": ["0f7fad2c-fc46-4ebc-b55b-6534da99e053"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-0158-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-0158-0", "marketing_start_date": "20250714"}], "brand_name": "Rosuvastatin", "product_id": "55154-0158_9baad60e-b35a-46f7-905f-f731c056961c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "55154-0158", "generic_name": "Rosuvastatin", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "10 mg/1"}], "application_number": "ANDA207616", "marketing_category": "ANDA", "marketing_start_date": "20250714", "listing_expiration_date": "20271231"}