FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
68788-8991
11-digit product format
687888991
Labeler code
68788
Product ID
68788-8991_b8bbe9fd-5169-484e-b51e-815b71ce10c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090548
Marketing category
ANDA
Marketing start
2016-02-16
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
80 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68788-8991-12020-01-31C16284748780-19d75b9d0-ae64-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68788-8991-32020-01-31C16284748780-19d75b9d0-ae64-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68788-8991-62020-01-31C16284748780-19d75b9d0-ae64-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996
68788-8991-92020-01-31C16284748780-19d75b9d0-ae64-f424-e053-dadaa90a57ceThese 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 administration Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8991-1ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1002
68788-8991-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED302
68788-8991-6ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED602
68788-8991-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8991ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Legacy NDC, 4 package rows20170510_3acd0923-5b1b-4da7-86c8-ba3b387b411a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259255atorvastatin calcium 80 MG Oral TabletPSN3acd0923-5b1b-4da7-86c8-ba3b387b411a2
259255atorvastatin 80 MG Oral TabletSCD3acd0923-5b1b-4da7-86c8-ba3b387b411a2
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY3acd0923-5b1b-4da7-86c8-ba3b387b411a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-8991-168788899101100 in 1 BOTTLEHistorical
68788-8991-36878889910330 in 1 BOTTLEHistorical
68788-8991-66878889910660 in 1 BOTTLEHistorical
68788-8991-96878889910990 in 1 BOTTLEHistorical