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 10 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-2539
Product ID 71335-2539_c6941a72-abca-4e4c-a315-b7d054702720
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206381
Listing Expiration 2026-12-31
Marketing Start 2019-04-24

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713352539
Hyphenated Format 71335-2539

Supplemental Identifiers

RxCUI
859747
UNII
413KH5ZJ73
NUI
N0000175589 N0000000121

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 ANDA206381 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-2539-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-2539-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-2539-3)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-2539-4)
  • 180 TABLET, FILM COATED in 1 BOTTLE (71335-2539-5)
  • 100 TABLET, FILM COATED in 1 BOTTLE (71335-2539-6)
source: ndc

Packages (6)

71335-2539-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-2539-1) 71335-2539-2 90 TABLET, FILM COATED in 1 BOTTLE (71335-2539-2) 71335-2539-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-2539-3) 71335-2539-4 120 TABLET, FILM COATED in 1 BOTTLE (71335-2539-4) 71335-2539-5 180 TABLET, FILM COATED in 1 BOTTLE (71335-2539-5) 71335-2539-6 100 TABLET, FILM COATED in 1 BOTTLE (71335-2539-6)

Ingredients (1)

rosuvastatin (10 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": "c6941a72-abca-4e4c-a315-b7d054702720", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["413KH5ZJ73"], "rxcui": ["859747"], "spl_set_id": ["e7955483-fecd-4376-b177-c669f862a3ac"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2539-1)", "package_ndc": "71335-2539-1", "marketing_start_date": "20241210"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-2539-2)", "package_ndc": "71335-2539-2", "marketing_start_date": "20241210"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-2539-3)", "package_ndc": "71335-2539-3", "marketing_start_date": "20241210"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-2539-4)", "package_ndc": "71335-2539-4", "marketing_start_date": "20241210"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (71335-2539-5)", "package_ndc": "71335-2539-5", "marketing_start_date": "20241210"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (71335-2539-6)", "package_ndc": "71335-2539-6", "marketing_start_date": "20241210"}], "brand_name": "Rosuvastatin", "product_id": "71335-2539_c6941a72-abca-4e4c-a315-b7d054702720", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71335-2539", "generic_name": "Rosuvastatin", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA206381", "marketing_category": "ANDA", "marketing_start_date": "20190424", "listing_expiration_date": "20261231"}