rosuvastatin

Generic: rosuvastatin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin
Generic Name rosuvastatin
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin 20 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8698
Product ID 68788-8698_14ef347e-6761-4350-a33f-c3c3c4bcbab5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206381
Listing Expiration 2026-12-31
Marketing Start 2024-06-14

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 687888698
Hyphenated Format 68788-8698

Supplemental Identifiers

RxCUI
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
  • 20 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8698-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8698-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8698-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8698-9)
source: ndc

Packages (4)

68788-8698-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8698-2) 68788-8698-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8698-3) 68788-8698-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8698-6) 68788-8698-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8698-9)

Ingredients (1)

rosuvastatin (20 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": "14ef347e-6761-4350-a33f-c3c3c4bcbab5", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["413KH5ZJ73"], "rxcui": ["859751"], "spl_set_id": ["d91dd29a-bb29-4193-a849-840f8696f658"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8698-2)", "package_ndc": "68788-8698-2", "marketing_start_date": "20240614"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8698-3)", "package_ndc": "68788-8698-3", "marketing_start_date": "20240614"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8698-6)", "package_ndc": "68788-8698-6", "marketing_start_date": "20240614"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8698-9)", "package_ndc": "68788-8698-9", "marketing_start_date": "20240614"}], "brand_name": "Rosuvastatin", "product_id": "68788-8698_14ef347e-6761-4350-a33f-c3c3c4bcbab5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8698", "generic_name": "Rosuvastatin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin", "active_ingredients": [{"name": "ROSUVASTATIN", "strength": "20 mg/1"}], "application_number": "ANDA206381", "marketing_category": "ANDA", "marketing_start_date": "20240614", "listing_expiration_date": "20261231"}