ATORVASTATIN CALCIUM

Product NDC
43353-892
11-digit product format
433530892
Labeler code
43353
Product ID
43353-892_cdb75f3a-bd50-4718-bdd3-0bd3cff8117f
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
2011-11-30
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
43353-892-09ATORVASTATIN CALCIUM9000 in 1 BOTTLE, PLASTICTABLET, FILM COATED90004
43353-892-45ATORVASTATIN CALCIUM45 in 1 BOTTLE, PLASTICTABLET, FILM COATED454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-892ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 2 package rows20191221_1b1faadc-b8b5-4545-a12b-060a90881aec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN1b1faadc-b8b5-4545-a12b-060a90881aec4
617311atorvastatin calcium 40 MG Oral TabletPSN1b1faadc-b8b5-4545-a12b-060a90881aec4
259255atorvastatin calcium 80 MG Oral TabletPSN1b1faadc-b8b5-4545-a12b-060a90881aec4
617310atorvastatin 20 MG Oral TabletSCD1b1faadc-b8b5-4545-a12b-060a90881aec4
617311atorvastatin 40 MG Oral TabletSCD1b1faadc-b8b5-4545-a12b-060a90881aec4
259255atorvastatin 80 MG Oral TabletSCD1b1faadc-b8b5-4545-a12b-060a90881aec4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY1b1faadc-b8b5-4545-a12b-060a90881aec4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1b1faadc-b8b5-4545-a12b-060a90881aec4
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY1b1faadc-b8b5-4545-a12b-060a90881aec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-892-09433530892099000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-892-09) 2014-02-260000-00-00NoNoCurrent
43353-892-454335308924545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-892-45) 2016-01-210000-00-00NoNoCurrent