FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
68258-6992
11-digit product format
682586992
Labeler code
68258
Product ID
68258-6992_cbd5e14a-1476-490d-8ab4-308ea767b51f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA076477
Marketing category
ANDA
Marketing start
2011-12-01
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68258-6992-92019-11-27C16284748780-19855d018-d96d-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use atorvastatin calcium 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
68258-6992-9Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
METHYLCELLULOSE (400 CPS)INACTIVE INGREDIENTO0GN6F9B2YATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYSORBATE 65INACTIVE INGREDIENT14BGY2Y3MJATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-6992ATORVASTATIN CALCIUM TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]2Legacy NDC, 1 package rows20130116_263f60b2-355e-4389-b47f-146854184da8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN263f60b2-355e-4389-b47f-146854184da82
617310atorvastatin calcium 20 MG Oral TabletPSN263f60b2-355e-4389-b47f-146854184da82
617312atorvastatin 10 MG Oral TabletSCD263f60b2-355e-4389-b47f-146854184da82
617310atorvastatin 20 MG Oral TabletSCD263f60b2-355e-4389-b47f-146854184da82
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY263f60b2-355e-4389-b47f-146854184da82
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY263f60b2-355e-4389-b47f-146854184da82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68258-6992-96825869920990 in 1 BOTTLEHistorical