rosuvastatin

Generic: rosuvastatin

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

Drug Facts

Product Profile

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

rosuvastatin 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-797
Product ID 71610-797_1300cf91-1b5b-05dd-e063-6294a90a4b62
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206381
Listing Expiration 2026-12-31
Marketing Start 2019-04-24

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610797
Hyphenated Format 71610-797

Supplemental Identifiers

RxCUI
859747
UNII
413KH5ZJ73
NUI
N0000175589 N0000000121

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 ANDA206381 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-797-15)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-797-45)
source: ndc

Packages (2)

71610-797-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-797-15) 71610-797-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-797-45)

Ingredients (1)

rosuvastatin (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": "1300cf91-1b5b-05dd-e063-6294a90a4b62", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["413KH5ZJ73"], "rxcui": ["859747"], "spl_set_id": ["11831846-b3ba-ba0b-e063-6394a90a4cb2"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-797-15)", "package_ndc": "71610-797-15", "marketing_start_date": "20240306"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-797-45)", "package_ndc": "71610-797-45", "marketing_start_date": "20240216"}], "brand_name": "Rosuvastatin", "product_id": "71610-797_1300cf91-1b5b-05dd-e063-6294a90a4b62", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-797", "generic_name": "Rosuvastatin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA206381", "marketing_category": "ANDA", "marketing_start_date": "20190424", "listing_expiration_date": "20261231"}