FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
63739-020
11-digit product format
637390020
Labeler code
63739
Product ID
63739-020_b4c9f959-9670-92bd-e053-2995a90ae6f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
Mckesson Corporation DBA SKY Packaginng
Application
ANDA091650
Marketing category
ANDA
Marketing start
2012-07-17
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
63739-020-102023-01-30C16284748780-1ab0e2407-2e1c-f274-e053-dbdaa90a6471These 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
63739-020-102020-07-22C16284748780-1ab0e2407-2e1c-f274-e053-dbdaa90a6471These 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
63739-020-10Atorvastatin Calcium10 in 1 BLISTER PACKTABLET106
63739-020-10Atorvastatin Calcium10 in 1 CASETABLET106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-020-10EA - Each63739-02020e88eef-c79c-41dd-be4b-bf559bef1eb912020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-020ATORVASTATIN CALCIUM TABLET [MCKESSON CORPORATION DBA SKY PACKAGINNG]6Legacy NDC, 2 package rows20211114_eab51d98-81bc-465f-9899-eec94d89aab5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNeab51d98-81bc-465f-9899-eec94d89aab56
617310atorvastatin calcium 20 MG Oral TabletPSNeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin calcium 40 MG Oral TabletPSNeab51d98-81bc-465f-9899-eec94d89aab56
617312atorvastatin 10 MG Oral TabletSCDeab51d98-81bc-465f-9899-eec94d89aab56
617310atorvastatin 20 MG Oral TabletSCDeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin 40 MG Oral TabletSCDeab51d98-81bc-465f-9899-eec94d89aab56
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYeab51d98-81bc-465f-9899-eec94d89aab56
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYeab51d98-81bc-465f-9899-eec94d89aab56
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYeab51d98-81bc-465f-9899-eec94d89aab56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-020-106373900201010 BLISTER PACK in 1 CASE (63739-020-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2020-02-170000-00-00NoNoCurrent