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
Routes
ORAL
Active Ingredients

atorvastatin 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-531
Product ID 72189-531_0e24e7cb-194a-6686-e063-6394a90a4760
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213853
Listing Expiration 2026-12-31
Marketing Start 2024-01-04

Pharmacologic Class

Established (EPC)
hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189531
Hyphenated Format 72189-531

Supplemental Identifiers

RxCUI
617312
UNII
A0JWA85V8F
NUI
N0000175589 N0000000121

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 ANDA213853 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (72189-531-90)
source: ndc

Packages (1)

72189-531-90 90 TABLET in 1 BOTTLE (72189-531-90)

Ingredients (1)

atorvastatin (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": "0e24e7cb-194a-6686-e063-6394a90a4760", "openfda": {"nui": ["N0000175589", "N0000000121"], "unii": ["A0JWA85V8F"], "rxcui": ["617312"], "spl_set_id": ["0e24e7cb-1949-6686-e063-6394a90a4760"], "pharm_class_epc": ["HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-531-90)", "package_ndc": "72189-531-90", "marketing_start_date": "20240104"}], "brand_name": "Atorvastatin Calcium", "product_id": "72189-531_0e24e7cb-194a-6686-e063-6394a90a4760", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "72189-531", "generic_name": "Atorvastatin Calcium", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Atorvastatin Calcium", "active_ingredients": [{"name": "ATORVASTATIN", "strength": "10 mg/1"}], "application_number": "ANDA213853", "marketing_category": "ANDA", "marketing_start_date": "20240104", "listing_expiration_date": "20261231"}