FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
53002-2439
11-digit product format
530022439
Labeler code
53002
Product ID
53002-2439_98e1ec12-2487-4b31-ba9c-d4bbd28bce01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA207687
Marketing category
ANDA
Marketing start
2018-08-02
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
2021-12-31
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
53002-2439-02023-01-30C16284748780-1f386c649-be12-0266-e053-dadaa90a7c1aThese 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
53002-2439-32023-01-30C16284748780-1f386c649-be12-0266-e053-dadaa90a7c1aThese 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
53002-2439-92023-01-30C16284748780-1f386c649-be12-0266-e053-dadaa90a7c1aThese 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
53002-2439-0ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1001
53002-2439-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED301
53002-2439-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2439ATORVASTATIN CALCIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 3 package rows20201222_328b2554-2870-4747-8256-21e522c15e13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN328b2554-2870-4747-8256-21e522c15e131
617312atorvastatin 10 MG Oral TabletSCD328b2554-2870-4747-8256-21e522c15e131
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY328b2554-2870-4747-8256-21e522c15e131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2439-053002243900100 TABLET, FILM COATED in 1 BOTTLE (53002-2439-0) 2020-01-010000-00-00NoNoCurrent
53002-2439-35300224390330 TABLET, FILM COATED in 1 BOTTLE (53002-2439-3) 2020-01-010000-00-00NoNoCurrent
53002-2439-95300224390990 TABLET, FILM COATED in 1 BOTTLE (53002-2439-9) 2020-01-010000-00-00NoNoCurrent