rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-458
Product ID 51655-458_49edce56-5dea-0b5c-e063-6394a90a84a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079172
Listing Expiration 2027-12-31
Marketing Start 2023-05-09

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 51655458
Hyphenated Format 51655-458

Supplemental Identifiers

RxCUI
859424
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 calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA079172 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-458-52)
source: ndc

Packages (1)

51655-458-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-458-52)

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": "49edce56-5dea-0b5c-e063-6394a90a84a2", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424"], "spl_set_id": ["1d86f10c-1e47-cefc-e063-6394a90a9f2e"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-458-52)", "package_ndc": "51655-458-52", "marketing_start_date": "20230509"}], "brand_name": "Rosuvastatin calcium", "product_id": "51655-458_49edce56-5dea-0b5c-e063-6394a90a84a2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "51655-458", "generic_name": "Rosuvastatin calcium", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA079172", "marketing_category": "ANDA", "marketing_start_date": "20230509", "listing_expiration_date": "20271231"}