FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
63629-8031
11-digit product format
636298031
Labeler code
63629
Product ID
63629-8031_a8698ee8-296c-461b-aa1e-41b2b141ddb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091624
Marketing category
ANDA
Marketing start
2013-04-05
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
2023-12-31
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
63629-8031-12024-01-30C16284748780-11030e365-612b-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1996
63629-8031-22024-01-30C16284748780-11030e365-612b-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8031-1Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED303
63629-8031-2Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8031ATORVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]3Legacy NDC, 2 package rows20220119_a8698ee8-296c-461b-aa1e-41b2b141ddb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSNa8698ee8-296c-461b-aa1e-41b2b141ddb03
617312atorvastatin 10 MG Oral TabletSCDa8698ee8-296c-461b-aa1e-41b2b141ddb03
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSYa8698ee8-296c-461b-aa1e-41b2b141ddb03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8031-16362980310130 TABLET, FILM COATED in 1 BOTTLE (63629-8031-1) 2021-12-230000-00-00NoNoCurrent
63629-8031-26362980310290 TABLET, FILM COATED in 1 BOTTLE (63629-8031-2) 2019-08-280000-00-00NoNoCurrent