rosuvastatin

Generic: rosuvastatin

Labeler: golden state medical supply, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler golden state medical supply, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin 10 mg/1

Manufacturer
Golden State Medical Supply, Inc.

Identifiers & Regulatory

Product NDC 51407-849
Product ID 51407-849_32d8af6b-ed18-ad03-e063-6394a90a078d
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 51407849
Hyphenated Format 51407-849

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
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
  • 1000 TABLET, FILM COATED in 1 BOTTLE (51407-849-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (51407-849-90)
source: ndc

Packages (2)

51407-849-10 1000 TABLET, FILM COATED in 1 BOTTLE (51407-849-10) 51407-849-90 90 TABLET, FILM COATED in 1 BOTTLE (51407-849-90)

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": "32d8af6b-ed18-ad03-e063-6394a90a078d", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["413KH5ZJ73"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["0f02c184-49f3-8fa6-e063-6394a90a5092"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Golden State Medical Supply, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (51407-849-10)", "package_ndc": "51407-849-10", "marketing_start_date": "20231218"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (51407-849-90)", "package_ndc": "51407-849-90", "marketing_start_date": "20231218"}], "brand_name": "Rosuvastatin", "product_id": "51407-849_32d8af6b-ed18-ad03-e063-6394a90a078d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "51407-849", "generic_name": "Rosuvastatin", "labeler_name": "Golden State Medical Supply, Inc.", "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"}