rosuvastatin calcium

Generic: rosuvastatin calcium

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

Drug Facts

Product Profile

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

rosuvastatin calcium 40 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3651
Product ID 70518-3651_468a9737-9b8c-ca54-e063-6394a90a7a8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207408
Listing Expiration 2026-12-31
Marketing Start 2023-02-19

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 705183651
Hyphenated Format 70518-3651

Supplemental Identifiers

RxCUI
859419
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 ANDA207408 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-0)
  • 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-1)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3651-2)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-3)
source: ndc

Packages (4)

70518-3651-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-0) 70518-3651-1 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-1) 70518-3651-2 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3651-2) 70518-3651-3 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-3)

Ingredients (1)

rosuvastatin calcium (40 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": "468a9737-9b8c-ca54-e063-6394a90a7a8a", "openfda": {"unii": ["83MVU38M7Q"], "rxcui": ["859419"], "spl_set_id": ["d9b83920-26ae-462a-ac10-33fd1ed7738f"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-0)", "package_ndc": "70518-3651-0", "marketing_start_date": "20230219"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-1)", "package_ndc": "70518-3651-1", "marketing_start_date": "20230222"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3651-2)", "package_ndc": "70518-3651-2", "marketing_start_date": "20230726"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3651-3)", "package_ndc": "70518-3651-3", "marketing_start_date": "20250421"}], "brand_name": "Rosuvastatin Calcium", "product_id": "70518-3651_468a9737-9b8c-ca54-e063-6394a90a7a8a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "70518-3651", "generic_name": "Rosuvastatin Calcium", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "40 mg/1"}], "application_number": "ANDA207408", "marketing_category": "ANDA", "marketing_start_date": "20230219", "listing_expiration_date": "20261231"}