Atorvastatin Calcium

Product NDC
53217-209
11-digit product format
532170209
Labeler code
53217
Product ID
53217-209_c8044251-d8ab-4ae5-aa96-e430ecec94db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA091624
Marketing category
ANDA
Marketing start
2013-04-05
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-209-30Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED302
53217-209-60Atorvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED602
53217-209-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902
53217-209-99Atorvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED1802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-209-30EA - Each53217-20984dcb632-7d86-45fd-b0eb-36e51e25279f12017-03-06
53217-209-60EA - Each53217-2098c147de9-5965-4cb3-9f3c-9c168c41d1dc12017-03-06
53217-209-90EA - Each53217-209ddb01ed1-6611-4980-83a6-103d2c5c4b1d12017-03-06
53217-209-99EA - Each53217-209402a01d4-8b47-4810-8010-8db546c6416812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-209ATORVASTATIN CALCIUM TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 4 package rows20170225_7e5afc60-41de-46c8-8d9a-6b252ee1404c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN7e5afc60-41de-46c8-8d9a-6b252ee1404c2
617310atorvastatin 20 MG Oral TabletSCD7e5afc60-41de-46c8-8d9a-6b252ee1404c2
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY7e5afc60-41de-46c8-8d9a-6b252ee1404c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-209-305321702093030 in 1 BOTTLEHistorical
53217-209-605321702096060 in 1 BOTTLEHistorical
53217-209-905321702099090 in 1 BOTTLEHistorical
53217-209-9953217020999180 in 1 BOTTLEHistorical