atorvastatin calcium

Generic: atorvastatin calcium

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atorvastatin calcium propylene glycol solvate 80 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-096
Product ID 50268-096_458c8ee9-c50c-c8bb-e063-6394a90a037b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090548
Listing Expiration 2026-12-31
Marketing Start 2016-06-28

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 50268096
Hyphenated Format 50268-096

Supplemental Identifiers

RxCUI
259255 617310 617311 617312
UNII
YRZ789OWMI

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
  • 80 mg/1
source: ndc
Packaging
  • 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-096-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-096-11)
source: ndc

Packages (1)

50268-096-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-096-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-096-11)

Ingredients (1)

atorvastatin calcium propylene glycol solvate (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": "458c8ee9-c50c-c8bb-e063-6394a90a037b", "openfda": {"unii": ["YRZ789OWMI"], "rxcui": ["259255", "617310", "617311", "617312"], "spl_set_id": ["b687ba81-cb24-bbdf-5dd9-ab0e53dd480b"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-096-12)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-096-11)", "package_ndc": "50268-096-12", "marketing_start_date": "20160628"}], "brand_name": "ATORVASTATIN CALCIUM", "product_id": "50268-096_458c8ee9-c50c-c8bb-e063-6394a90a037b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "50268-096", "generic_name": "ATORVASTATIN CALCIUM", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ATORVASTATIN CALCIUM", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE", "strength": "80 mg/1"}], "application_number": "ANDA090548", "marketing_category": "ANDA", "marketing_start_date": "20160628", "listing_expiration_date": "20261231"}