FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
68071-2585
11-digit product format
680712585
Labeler code
68071
Product ID
68071-2585_d21a9ead-c225-2817-e053-2995a90af961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2021-08-01
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
03fb3cda-d60a-4873-94e9-6fa77cfb1a1cProduct name120220302
34152997-af0b-acf4-dcaf-37211afe8ca4Product name920210312
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2585-92025-01-30C16284748780-1f386c649-df42-0266-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
68071-2585-92023-07-17C16284748780-1f386c649-df42-0266-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
68071-2585-92023-01-30C16284748780-1f386c649-df42-0266-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
68071-2585-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2585ATORVASTATIN CALCIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230718_d21a92f4-c669-7d19-e053-2a95a90a6d98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSNd21a92f4-c669-7d19-e053-2a95a90a6d982
617311atorvastatin 40 MG Oral TabletSCDd21a92f4-c669-7d19-e053-2a95a90a6d982
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYd21a92f4-c669-7d19-e053-2a95a90a6d982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2585-96807125850990 TABLET, FILM COATED in 1 BOTTLE (68071-2585-9) 2021-12-010000-00-00NoNoCurrent