rosuvastatin

Generic: rosuvastatin

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0749
Product ID 71335-0749_c60bc37b-8392-4a9f-8664-83056d2fae58
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 713350749
Hyphenated Format 71335-0749

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-0749-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-0749-2)
  • 28 TABLET, FILM COATED in 1 BOTTLE (71335-0749-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0749-4)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71335-0749-5)
source: ndc

Packages (5)

71335-0749-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0749-1) 71335-0749-2 90 TABLET, FILM COATED in 1 BOTTLE (71335-0749-2) 71335-0749-3 28 TABLET, FILM COATED in 1 BOTTLE (71335-0749-3) 71335-0749-4 60 TABLET, FILM COATED in 1 BOTTLE (71335-0749-4) 71335-0749-5 100 TABLET, FILM COATED in 1 BOTTLE (71335-0749-5)

Ingredients (1)

rosuvastatin calcium (5 mg/1)

Linked Drug Pages (1)

Rosuvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c60bc37b-8392-4a9f-8664-83056d2fae58", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424"], "spl_set_id": ["0ad5b7de-e97d-4989-91e4-edae73543896"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0749-1)", "package_ndc": "71335-0749-1", "marketing_start_date": "20180413"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0749-2)", "package_ndc": "71335-0749-2", "marketing_start_date": "20180321"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (71335-0749-3)", "package_ndc": "71335-0749-3", "marketing_start_date": "20211209"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0749-4)", "package_ndc": "71335-0749-4", "marketing_start_date": "20241030"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71335-0749-5)", "package_ndc": "71335-0749-5", "marketing_start_date": "20241030"}], "brand_name": "Rosuvastatin", "product_id": "71335-0749_c60bc37b-8392-4a9f-8664-83056d2fae58", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71335-0749", "generic_name": "Rosuvastatin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA206434", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}