atorvastatin calcium

Generic: atorvastatin calcium

Labeler: quallent
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name atorvastatin calcium
Generic Name atorvastatin calcium
Labeler quallent
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

atorvastatin calcium propylene glycol solvate 10 mg/1

Manufacturer
Quallent

Identifiers & Regulatory

Product NDC 82009-001
Product ID 82009-001_5c04b2a7-ceeb-a77b-fba1-ef8811d38669
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2026-12-31
Marketing Start 2021-11-23

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 82009001
Hyphenated Format 82009-001

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UNII
YRZ789OWMI

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 atorvastatin calcium (source: ndc)
Generic Name atorvastatin calcium (source: ndc)
Application Number ANDA090548 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (82009-001-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (82009-001-90)
source: ndc

Packages (2)

82009-001-10 1000 TABLET, FILM COATED in 1 BOTTLE (82009-001-10) 82009-001-90 90 TABLET, FILM COATED in 1 BOTTLE (82009-001-90)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (10 mg/1)

Linked Drug Pages (1)

ATORVASTATIN CALCIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5c04b2a7-ceeb-a77b-fba1-ef8811d38669", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["f00a83aa-3f1d-566d-b9bb-f396f22a27cb"], "manufacturer_name": ["Quallent"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (82009-001-10)", "package_ndc": "82009-001-10", "marketing_start_date": "20211123"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82009-001-90)", "package_ndc": "82009-001-90", "marketing_start_date": "20211123"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "82009-001_5c04b2a7-ceeb-a77b-fba1-ef8811d38669", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82009-001", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Quallent", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE", "strength": "10 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20211123", "listing_expiration_date": "20261231"}