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 20 mg/1

Manufacturer
Preferred Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68788-7612
Product ID 68788-7612_ca11474d-6cdb-4777-9c5a-7229dd83452e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208898
Listing Expiration 2026-12-31
Marketing Start 2020-06-01

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 687887612
Hyphenated Format 68788-7612

Supplemental Identifiers

RxCUI
859751
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 ANDA208898 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-7612-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-7612-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-7612-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-7612-9)
source: ndc

Packages (4)

68788-7612-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-7612-2) 68788-7612-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-7612-3) 68788-7612-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-7612-6) 68788-7612-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-7612-9)

Ingredients (1)

rosuvastatin calcium (20 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": "ca11474d-6cdb-4777-9c5a-7229dd83452e", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859751"], "spl_set_id": ["6ef51f7c-2899-4b09-bf8b-09e5b4ac3424"], "manufacturer_name": ["Preferred Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-7612-2)", "package_ndc": "68788-7612-2", "marketing_start_date": "20200601"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-7612-3)", "package_ndc": "68788-7612-3", "marketing_start_date": "20200601"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-7612-6)", "package_ndc": "68788-7612-6", "marketing_start_date": "20200601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-7612-9)", "package_ndc": "68788-7612-9", "marketing_start_date": "20200601"}], "brand_name": "Rosuvastatin Calcium", "product_id": "68788-7612_ca11474d-6cdb-4777-9c5a-7229dd83452e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68788-7612", "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": "20 mg/1"}], "application_number": "ANDA208898", "marketing_category": "ANDA", "marketing_start_date": "20200601", "listing_expiration_date": "20261231"}