FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
53808-0951
11-digit product format
538080951
Labeler code
53808
Product ID
53808-0951_0b17581a-4adf-4da1-ad3b-f15ebe08eb97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
NDA020702
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-01
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
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
53808-0951-12020-01-31C16284748780-19d75b9d0-0d7e-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
53808-0951-1ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0951ATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20141014_cc710d44-d515-4b17-a3c6-4d3ba9b049f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNcc710d44-d515-4b17-a3c6-4d3ba9b049f82
617310atorvastatin 20 MG Oral TabletSCDcc710d44-d515-4b17-a3c6-4d3ba9b049f82
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYcc710d44-d515-4b17-a3c6-4d3ba9b049f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0951-15380809510130 in 1 BLISTER PACKHistorical