Atorvastatin Calcium

Product NDC
43353-983
11-digit product format
433530983
Labeler code
43353
Product ID
43353-983_dad379a1-afd2-45d6-9cc1-ab8716bcb906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091624
Marketing category
ANDA
Marketing start
2013-07-08
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
80 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-983-15Atorvastatin Calcium15 in 1 BOTTLETABLET, FILM COATED151
43353-983-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED301
43353-983-45Atorvastatin Calcium45 in 1 BOTTLETABLET, FILM COATED451

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-983-15EA - Each43353-98395dbf2ca-4046-4403-af49-c219bc8644ac12016-07-19
43353-983-30EA - Each43353-9836c723137-48de-4bbe-8c9a-1207fb92811412016-07-19
43353-983-45EA - Each43353-983adfa81d3-fe7f-4e96-8108-0437cb0926e312016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-983ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20160708_a343576d-fffd-4e03-b67a-92a54388bc0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSNa343576d-fffd-4e03-b67a-92a54388bc0d1
259255atorvastatin 80 MG Oral TabletSCDa343576d-fffd-4e03-b67a-92a54388bc0d1
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSYa343576d-fffd-4e03-b67a-92a54388bc0d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-983-154335309831515 in 1 BOTTLEHistorical
43353-983-304335309833030 in 1 BOTTLEHistorical
43353-983-454335309834545 in 1 BOTTLEHistorical