rosuvastatin calcium

Generic: rosuvastatin calcium

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

Drug Facts

Product Profile

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

rosuvastatin calcium 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.,

Identifiers & Regulatory

Product NDC 68788-8368
Product ID 68788-8368_90b0a5b7-3559-4c11-b760-b694e73b51a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079172
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

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 687888368
Hyphenated Format 68788-8368

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 ANDA079172 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8368-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8368-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8368-9)
source: ndc

Packages (3)

68788-8368-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8368-3) 68788-8368-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8368-6) 68788-8368-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8368-9)

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": "90b0a5b7-3559-4c11-b760-b694e73b51a7", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859424"], "spl_set_id": ["e432e043-c019-4d58-94ca-7c1d85f5cd40"], "manufacturer_name": ["Preferred Pharmaceuticals Inc.,"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8368-3)", "package_ndc": "68788-8368-3", "marketing_start_date": "20230201"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8368-6)", "package_ndc": "68788-8368-6", "marketing_start_date": "20230201"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8368-9)", "package_ndc": "68788-8368-9", "marketing_start_date": "20230201"}], "brand_name": "Rosuvastatin calcium", "product_id": "68788-8368_90b0a5b7-3559-4c11-b760-b694e73b51a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-8368", "generic_name": "Rosuvastatin calcium", "labeler_name": "Preferred Pharmaceuticals Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA079172", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}