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
Routes
ORAL
Active Ingredients

rosuvastatin calcium 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-793
Product ID 71610-793_11be52c2-498c-fff4-e063-6294a90a67be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207752
Listing Expiration 2026-12-31
Marketing Start 2023-08-23

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 71610793
Hyphenated Format 71610-793

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 ANDA207752 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71610-793-15)
  • 45 TABLET in 1 BOTTLE (71610-793-45)
  • 90 TABLET in 1 BOTTLE (71610-793-60)
source: ndc

Packages (3)

71610-793-15 15 TABLET in 1 BOTTLE (71610-793-15) 71610-793-45 45 TABLET in 1 BOTTLE (71610-793-45) 71610-793-60 90 TABLET in 1 BOTTLE (71610-793-60)

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": "11be52c2-498c-fff4-e063-6294a90a67be", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419"], "spl_set_id": ["113160c7-7b41-5395-e063-6394a90a1e15"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71610-793-15)", "package_ndc": "71610-793-15", "marketing_start_date": "20240131"}, {"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-793-45)", "package_ndc": "71610-793-45", "marketing_start_date": "20240131"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-793-60)", "package_ndc": "71610-793-60", "marketing_start_date": "20240131"}], "brand_name": "ROSUVASTATIN CALCIUM", "product_id": "71610-793_11be52c2-498c-fff4-e063-6294a90a67be", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-793", "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": "ANDA207752", "marketing_category": "ANDA", "marketing_start_date": "20230823", "listing_expiration_date": "20261231"}