FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
45865-727
11-digit product format
458650727
Labeler code
45865
Product ID
45865-727_7d780c61-9993-33bf-e053-2a91aa0a3045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA205300
Marketing category
ANDA
Marketing start
2017-05-04
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-727-492020-01-31C16284748780-19d75b9d0-c442-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 use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-727-49Atorvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-727ATORVASTATIN CALCIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 1 package rows20181221_7d780c61-9992-33bf-e053-2a91aa0a3045.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN7d780c61-9992-33bf-e053-2a91aa0a30452
617311atorvastatin 40 MG Oral TabletSCD7d780c61-9992-33bf-e053-2a91aa0a30452
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7d780c61-9992-33bf-e053-2a91aa0a30452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-727-4945865072749100 in 1 BOTTLEHistorical