ATORVASTATIN CALCIUM

Product NDC
0440-7128
11-digit product format
004407128
Labeler code
0440
Product ID
0440-7128_6bd17203-4f17-48d0-a5c9-b80e0df8cdf5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2012-05-29
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-7128-302020-01-31C16284748780-19d75b9d0-f223-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral administration Initial U.S. Approval: 1996
0440-7128-602020-01-31C16284748780-19d75b9d0-f223-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral administration Initial U.S. Approval: 1996
0440-7128-812020-01-31C16284748780-19d75b9d0-f223-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral administration Initial U.S. Approval: 1996
0440-7128-852020-01-31C16284748780-19d75b9d0-f223-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral administration Initial U.S. Approval: 1996
0440-7128-902020-01-31C16284748780-19d75b9d0-f223-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral administration Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7128-30ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
0440-7128-60ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED601
0440-7128-81ATORVASTATIN CALCIUM300 in 1 BOTTLETABLET, FILM COATED3001
0440-7128-85ATORVASTATIN CALCIUM800 in 1 BOTTLETABLET, FILM COATED8001
0440-7128-90ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7128ATORVASTATIN CALCIUM TABLET, FILM COATED [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 5 package rows20160813_fdfba989-7618-44ec-9ce1-8bff97c4a646.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSNfdfba989-7618-44ec-9ce1-8bff97c4a6461
259255atorvastatin 80 MG Oral TabletSCDfdfba989-7618-44ec-9ce1-8bff97c4a6461
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYfdfba989-7618-44ec-9ce1-8bff97c4a6461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7128-300044071283030 in 1 BOTTLEHistorical
0440-7128-600044071286060 in 1 BOTTLEHistorical
0440-7128-8100440712881300 in 1 BOTTLEHistorical
0440-7128-8500440712885800 in 1 BOTTLEHistorical
0440-7128-900044071289090 in 1 BOTTLEHistorical