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 80 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-537
Product ID 72189-537_4c4a77d3-dc1f-704f-e063-6394a90ad5a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211933
Listing Expiration 2027-12-31
Marketing Start 2024-02-26

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 72189537
Hyphenated Format 72189-537

Supplemental Identifiers

RxCUI
259255
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
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-537-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-537-90)
source: ndc

Packages (2)

72189-537-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-537-30) 72189-537-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-537-90)

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": "4c4a77d3-dc1f-704f-e063-6394a90ad5a6", "openfda": {"unii": ["48A5M73Z4Q"], "rxcui": ["259255"], "spl_set_id": ["124c111c-9272-eca9-e063-6394a90a0ad5"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-537-30)", "package_ndc": "72189-537-30", "marketing_start_date": "20240226"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-537-90)", "package_ndc": "72189-537-90", "marketing_start_date": "20240226"}], "brand_name": "Atorvastatin Calcium", "product_id": "72189-537_4c4a77d3-dc1f-704f-e063-6394a90ad5a6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72189-537", "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": "80 mg/1"}], "application_number": "ANDA211933", "marketing_category": "ANDA", "marketing_start_date": "20240226", "listing_expiration_date": "20271231"}