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 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-215
Product ID 71610-215_8829f5bc-538d-4ad6-ad8b-04e28da01924
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 71610215
Hyphenated Format 71610-215

Supplemental Identifiers

RxCUI
859747
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
  • 10 mg/1
source: ndc
Packaging
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-215-45)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-215-60)
source: ndc

Packages (2)

71610-215-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-215-45) 71610-215-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-215-60)

Ingredients (1)

rosuvastatin calcium (10 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": "8829f5bc-538d-4ad6-ad8b-04e28da01924", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859747"], "spl_set_id": ["a5ee9510-e691-49ec-a5cd-49e70371ee4d"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-215-45)", "package_ndc": "71610-215-45", "marketing_start_date": "20181231"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-215-60)", "package_ndc": "71610-215-60", "marketing_start_date": "20181231"}], "brand_name": "Rosuvastatin calcium", "product_id": "71610-215_8829f5bc-538d-4ad6-ad8b-04e28da01924", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-215", "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": "10 mg/1"}], "application_number": "ANDA206434", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}