rosuvastatin calcium

Generic: rosuvastatin calcium

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

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
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 71335-1889
Product ID 71335-1889_15200cab-6cc5-4bf2-a492-ca94fc25e656
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207752
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 713351889
Hyphenated Format 71335-1889

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 calcium (source: ndc)
Generic Name rosuvastatin calcium (source: ndc)
Application Number ANDA207752 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-2)
  • 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-4)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-5)
source: ndc

Packages (5)

71335-1889-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-1) 71335-1889-2 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-2) 71335-1889-3 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-3) 71335-1889-4 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-4) 71335-1889-5 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-5)

Ingredients (1)

rosuvastatin calcium (5 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": "15200cab-6cc5-4bf2-a492-ca94fc25e656", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424"], "spl_set_id": ["e41da8b8-db23-49e1-9ee0-55423d285980"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-1)", "package_ndc": "71335-1889-1", "marketing_start_date": "20210902"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-2)", "package_ndc": "71335-1889-2", "marketing_start_date": "20210730"}, {"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-3)", "package_ndc": "71335-1889-3", "marketing_start_date": "20211104"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-4)", "package_ndc": "71335-1889-4", "marketing_start_date": "20220310"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1889-5)", "package_ndc": "71335-1889-5", "marketing_start_date": "20220310"}], "brand_name": "Rosuvastatin calcium", "product_id": "71335-1889_15200cab-6cc5-4bf2-a492-ca94fc25e656", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71335-1889", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA207752", "marketing_category": "ANDA", "marketing_start_date": "20161031", "listing_expiration_date": "20261231"}