rosuvastatin calcium

Generic: rosuvastatin calcium

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rosuvastatin calcium
Generic Name rosuvastatin calcium
Labeler novadoz pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rosuvastatin calcium 20 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-004
Product ID 72205-004_62787a4a-6d53-43a3-a0b7-ed0b6037d18e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208898
Listing Expiration 2026-12-31
Marketing Start 2017-11-22

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 72205004
Hyphenated Format 72205-004

Supplemental Identifiers

RxCUI
859419 859424 859747 859751
UPC
0372205027053 0372205004993 0372205005990 0372205027992 0372205003903 0372205004900 0372205005051 0372205003996 0372205004054 0372205027909 0372205005907 0372205005303 0372205003057
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 ANDA208898 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (72205-004-05)
  • 100 BLISTER PACK in 1 CARTON (72205-004-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-004-11)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72205-004-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72205-004-99)
source: ndc

Packages (4)

72205-004-05 500 TABLET, FILM COATED in 1 BOTTLE (72205-004-05) 72205-004-06 100 BLISTER PACK in 1 CARTON (72205-004-06) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-004-11) 72205-004-90 90 TABLET, FILM COATED in 1 BOTTLE (72205-004-90) 72205-004-99 1000 TABLET, FILM COATED in 1 BOTTLE (72205-004-99)

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": "62787a4a-6d53-43a3-a0b7-ed0b6037d18e", "openfda": {"upc": ["0372205027053", "0372205004993", "0372205005990", "0372205027992", "0372205003903", "0372205004900", "0372205005051", "0372205003996", "0372205004054", "0372205027909", "0372205005907", "0372205005303", "0372205003057"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["d58f1f63-4bb6-413c-9730-ded3e8078618"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72205-004-05)", "package_ndc": "72205-004-05", "marketing_start_date": "20190225"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (72205-004-06)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-004-11)", "package_ndc": "72205-004-06", "marketing_start_date": "20171122"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72205-004-90)", "package_ndc": "72205-004-90", "marketing_start_date": "20171122"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72205-004-99)", "package_ndc": "72205-004-99", "marketing_start_date": "20171122"}], "brand_name": "Rosuvastatin Calcium", "product_id": "72205-004_62787a4a-6d53-43a3-a0b7-ed0b6037d18e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72205-004", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Novadoz Pharmaceuticals LLC", "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": "20171122", "listing_expiration_date": "20261231"}