atorvastatin calcium

Generic: atorvastatin calcium

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

atorvastatin calcium trihydrate 40 mg/1

Manufacturer
Direct_rx

Identifiers & Regulatory

Product NDC 72189-557
Product ID 72189-557_339eff5f-588e-3a5b-e063-6294a90abed0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211933
Listing Expiration 2026-12-31
Marketing Start 2024-06-14

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 72189557
Hyphenated Format 72189-557

Supplemental Identifiers

RxCUI
617311
UNII
48A5M73Z4Q

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 ANDA211933 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-557-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-557-90)
source: ndc

Packages (2)

72189-557-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-557-30) 72189-557-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-557-90)

Ingredients (1)

atorvastatin calcium trihydrate (40 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": "339eff5f-588e-3a5b-e063-6294a90abed0", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["617311"], "spl_set_id": ["1ade00fd-5eb4-f67a-e063-6294a90a9112"], "manufacturer_name": ["Direct_rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-557-30)", "package_ndc": "72189-557-30", "marketing_start_date": "20240614"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-557-90)", "package_ndc": "72189-557-90", "marketing_start_date": "20240614"}], "brand_name": "Atorvastatin Calcium", "product_id": "72189-557_339eff5f-588e-3a5b-e063-6294a90abed0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72189-557", "generic_name": "Atorvastatin Calcium", "labeler_name": "Direct_rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN CALCIUM TRIHYDRATE", "strength": "40 mg/1"}], "application_number": "ANDA211933", "marketing_category": "ANDA", "marketing_start_date": "20240614", "listing_expiration_date": "20261231"}