rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: glenmark pharmaceutials inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rosuvastatin calcium 5 mg/1

Manufacturer
Glenmark Pharmaceutials Inc., USA

Identifiers & Regulatory

Product NDC 68462-261
Product ID 68462-261_958b8936-9395-42e0-8c3b-3247a20621c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079172
Listing Expiration 2026-12-31
Marketing Start 2016-07-19

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 68462261
Hyphenated Format 68462-261

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0368462263907 0368462261903 0368462262900 0368462264300
UNII
83MVU38M7Q

Packaging Origin

Original Packager
true

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
  • 100 TABLET, FILM COATED in 1 BOTTLE (68462-261-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (68462-261-10)
  • 10 BLISTER PACK in 1 CARTON (68462-261-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (68462-261-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (68462-261-50)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68462-261-90)
source: ndc

Packages (6)

68462-261-01 100 TABLET, FILM COATED in 1 BOTTLE (68462-261-01) 68462-261-10 1000 TABLET, FILM COATED in 1 BOTTLE (68462-261-10) 68462-261-11 10 BLISTER PACK in 1 CARTON (68462-261-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK 68462-261-30 30 TABLET, FILM COATED in 1 BOTTLE (68462-261-30) 68462-261-50 50 TABLET, FILM COATED in 1 BOTTLE (68462-261-50) 68462-261-90 90 TABLET, FILM COATED in 1 BOTTLE (68462-261-90)

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": "958b8936-9395-42e0-8c3b-3247a20621c4", "openfda": {"upc": ["0368462263907", "0368462261903", "0368462262900", "0368462264300"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["392657a9-955c-42c2-814c-1890ece45afa"], "manufacturer_name": ["Glenmark Pharmaceutials Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68462-261-01)", "package_ndc": "68462-261-01", "marketing_start_date": "20160719"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (68462-261-10)", "package_ndc": "68462-261-10", "marketing_start_date": "20160719"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68462-261-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "68462-261-11", "marketing_start_date": "20160719"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68462-261-30)", "package_ndc": "68462-261-30", "marketing_start_date": "20160719"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (68462-261-50)", "package_ndc": "68462-261-50", "marketing_start_date": "20160719"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68462-261-90)", "package_ndc": "68462-261-90", "marketing_start_date": "20160719"}], "brand_name": "Rosuvastatin calcium", "product_id": "68462-261_958b8936-9395-42e0-8c3b-3247a20621c4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "68462-261", "generic_name": "Rosuvastatin calcium", "labeler_name": "Glenmark Pharmaceutials Inc., USA", "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": "20160719", "listing_expiration_date": "20261231"}