rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-078
Product ID 71610-078_e0971976-733b-496e-8d1a-93bb656ba57a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206434
Listing Expiration 2026-12-31
Marketing Start 2016-10-31

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 71610078
Hyphenated Format 71610-078

Supplemental Identifiers

RxCUI
859419
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 ANDA206434 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-078-15)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-078-45)
source: ndc

Packages (2)

71610-078-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-078-15) 71610-078-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-078-45)

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": "e0971976-733b-496e-8d1a-93bb656ba57a", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419"], "spl_set_id": ["69dfa637-2a81-4c7e-8fef-d4b4ab4c3f25"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-078-15)", "package_ndc": "71610-078-15", "marketing_start_date": "20180612"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-078-45)", "package_ndc": "71610-078-45", "marketing_start_date": "20180525"}], "brand_name": "Rosuvastatin calcium", "product_id": "71610-078_e0971976-733b-496e-8d1a-93bb656ba57a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-078", "generic_name": "Rosuvastatin calcium", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA206434", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}