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 71610-232
Product ID 71610-232_e177d76d-1ef4-4218-9e40-07cdf617857b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207408
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 71610232
Hyphenated Format 71610-232

Supplemental Identifiers

RxCUI
859419 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 calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA207408 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (71610-232-15)
  • 6000 TABLET, FILM COATED in 1 BOTTLE (71610-232-16)
  • 3000 TABLET, FILM COATED in 1 BOTTLE (71610-232-18)
  • 1800 TABLET, FILM COATED in 1 BOTTLE (71610-232-42)
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-232-45)
source: ndc

Packages (5)

71610-232-15 15 TABLET, FILM COATED in 1 BOTTLE (71610-232-15) 71610-232-16 6000 TABLET, FILM COATED in 1 BOTTLE (71610-232-16) 71610-232-18 3000 TABLET, FILM COATED in 1 BOTTLE (71610-232-18) 71610-232-42 1800 TABLET, FILM COATED in 1 BOTTLE (71610-232-42) 71610-232-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-232-45)

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": "e177d76d-1ef4-4218-9e40-07cdf617857b", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419", "859747", "859751"], "spl_set_id": ["ab6c1601-5152-443c-98a0-876660d533e8"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71610-232-15)", "package_ndc": "71610-232-15", "marketing_start_date": "20190201"}, {"sample": false, "description": "6000 TABLET, FILM COATED in 1 BOTTLE (71610-232-16)", "package_ndc": "71610-232-16", "marketing_start_date": "20190208"}, {"sample": false, "description": "3000 TABLET, FILM COATED in 1 BOTTLE (71610-232-18)", "package_ndc": "71610-232-18", "marketing_start_date": "20230317"}, {"sample": false, "description": "1800 TABLET, FILM COATED in 1 BOTTLE (71610-232-42)", "package_ndc": "71610-232-42", "marketing_start_date": "20230217"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-232-45)", "package_ndc": "71610-232-45", "marketing_start_date": "20190201"}], "brand_name": "Rosuvastatin Calcium", "product_id": "71610-232_e177d76d-1ef4-4218-9e40-07cdf617857b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-232", "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": "ANDA207408", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}