rosuvastatin calcium (82009-017)

Drug Facts

Product Profile

Brand Name rosuvastatin calcium

Generic Name rosuvastatin calcium

Labeler quallent pharmaceuticals health llc

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

rosuvastatin calcium 5 mg/1

Manufacturer

Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-017

Product ID 82009-017_86597300-9b2c-44cf-9650-503f5bdbf5bb

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA208898

Listing Expiration 2027-12-31

Marketing Start 2022-03-09

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 82009017

Hyphenated Format 82009-017

Supplemental Identifiers

RxCUI

859419 859424 859747 859751

UPC

0382009019901 0382009020303 0382009018904 0382009017907

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

5 mg/1

source: ndc

Packaging

1000 TABLET, FILM COATED in 1 BOTTLE (82009-017-10)
90 TABLET, FILM COATED in 1 BOTTLE (82009-017-90)

source: ndc

Packages (2)

82009-017-10 1000 TABLET, FILM COATED in 1 BOTTLE (82009-017-10) 82009-017-90 90 TABLET, FILM COATED in 1 BOTTLE (82009-017-90)

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": "86597300-9b2c-44cf-9650-503f5bdbf5bb", "openfda": {"upc": ["0382009019901", "0382009020303", "0382009018904", "0382009017907"], "unii": ["83MVU38M7Q"], "rxcui": ["859419", "859424", "859747", "859751"], "spl_set_id": ["6f978191-775e-4745-9c07-99e5be888afe"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (82009-017-10)", "package_ndc": "82009-017-10", "marketing_start_date": "20220309"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82009-017-90)", "package_ndc": "82009-017-90", "marketing_start_date": "20220309"}], "brand_name": "Rosuvastatin Calcium", "product_id": "82009-017_86597300-9b2c-44cf-9650-503f5bdbf5bb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82009-017", "generic_name": "Rosuvastatin Calcium", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rosuvastatin Calcium", "active_ingredients": [{"name": "ROSUVASTATIN CALCIUM", "strength": "5 mg/1"}], "application_number": "ANDA208898", "marketing_category": "ANDA", "marketing_start_date": "20220309", "listing_expiration_date": "20271231"}