ATORVASTATIN CALCIUM

Product NDC
43353-120
11-digit product format
433530120
Labeler code
43353
Product ID
43353-120_67dce28b-a634-42eb-b565-93d513ab9b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020702
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-01-28
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-120-45ATORVASTATIN CALCIUM45 in 1 BOTTLETABLET, FILM COATED454
43353-120-60ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-120-60EA - Each43353-1201f9d1cb1-db76-4716-a7d5-fb9841e1259d12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-120ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 2 package rows20191219_b0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNb0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c4
617312atorvastatin 10 MG Oral TabletSCDb0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c4
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYb0f54cad-3ff2-4c3b-9ef1-b888c4d6c25c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-120-454335301204545 TABLET, FILM COATED in 1 BOTTLE (43353-120-45) 2015-11-040000-00-00NoNoCurrent
43353-120-604335301206090 TABLET, FILM COATED in 1 BOTTLE (43353-120-60) 2016-01-130000-00-00NoNoCurrent