rosuvastatin

Generic: rosuvastatin

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler direct rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-065
Product ID 72189-065_4c499576-6f7a-6e58-e063-6294a90ab6a0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208898
Listing Expiration 2027-12-31
Marketing Start 2019-12-10

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 72189065
Hyphenated Format 72189-065

Supplemental Identifiers

RxCUI
859419 859424
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 (source: ndc)
Generic Name rosuvastatin (source: ndc)
Application Number ANDA208898 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-065-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-065-90)
source: ndc

Packages (2)

72189-065-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-065-30) 72189-065-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-065-90)

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

ROSUVASTATIN, ROSUVASTATIN CALCIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4c499576-6f7a-6e58-e063-6294a90ab6a0", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424"], "spl_set_id": ["99602058-4681-7cb5-e053-2995a90a099c"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-065-30)", "package_ndc": "72189-065-30", "marketing_start_date": "20191210"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-065-90)", "package_ndc": "72189-065-90", "marketing_start_date": "20191210"}], "brand_name": "ROSUVASTATIN", "product_id": "72189-065_4c499576-6f7a-6e58-e063-6294a90ab6a0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72189-065", "generic_name": "ROSUVASTATIN", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ROSUVASTATIN", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA208898", "marketing_category": "ANDA", "marketing_start_date": "20191210", "listing_expiration_date": "20271231"}