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 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-187
Product ID 71610-187_4abd6ed8-17d4-44d1-a30e-956ce5cc46e1
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 71610187
Hyphenated Format 71610-187

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 45 TABLET, FILM COATED in 1 BOTTLE (71610-187-45)
source: ndc

Packages (1)

71610-187-45 45 TABLET, FILM COATED in 1 BOTTLE (71610-187-45)

Ingredients (1)

rosuvastatin calcium (20 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": "4abd6ed8-17d4-44d1-a30e-956ce5cc46e1", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859751"], "spl_set_id": ["410a0a03-6751-4c3d-82bf-c7c6a4081fdd"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (71610-187-45)", "package_ndc": "71610-187-45", "marketing_start_date": "20181102"}], "brand_name": "Rosuvastatin calcium", "product_id": "71610-187_4abd6ed8-17d4-44d1-a30e-956ce5cc46e1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-187", "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": "20 mg/1"}], "application_number": "ANDA206434", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}