atorvastatin calcium

Generic: atorvastatin calcium

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

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 80 mg/1

Manufacturer
Quallent Pharmaceuticals Health LLC

Identifiers & Regulatory

Product NDC 82009-179
Product ID 82009-179_3cc5dd82-b074-c0e2-e063-6394a90aa46e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214344
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

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 82009179
Hyphenated Format 82009-179

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UPC
0382009176109 3389449177106
UNII
48A5M73Z4Q

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 ANDA214344 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (82009-179-10)
source: ndc

Packages (1)

82009-179-10 1000 TABLET, FILM COATED in 1 BOTTLE (82009-179-10)

Ingredients (1)

atorvastatin calcium trihydrate (80 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": "3cc5dd82-b074-c0e2-e063-6394a90aa46e", "openfda": {"upc": ["0382009176109", "3389449177106"], "unii": ["48A5M73Z4Q"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["5b94b6f4-6f64-4551-abcb-8e845fb13813"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (82009-179-10)", "package_ndc": "82009-179-10", "marketing_start_date": "20250801"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "82009-179_3cc5dd82-b074-c0e2-e063-6394a90aa46e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "82009-179", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "80 mg/1"}], "application_number": "ANDA214344", "marketing_category": "ANDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}