FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
68788-9683
11-digit product format
687889683
Labeler code
68788
Product ID
68788-9683_0b1874b7-9002-4ca9-b136-df08b8cb4d40
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
2013-04-15
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE
Active strength
20 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
68788-9683-12020-01-31C16284748780-19d75b9d0-5692-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
68788-9683-32020-01-31C16284748780-19d75b9d0-5692-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
68788-9683-62020-01-31C16284748780-19d75b9d0-5692-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
68788-9683-92020-01-31C16284748780-19d75b9d0-5692-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
68788-9683-1ATORVASTATIN CALCIUM100 in 1 BOTTLETABLET, FILM COATED1004
68788-9683-3ATORVASTATIN CALCIUM30 in 1 BOTTLETABLET, FILM COATED304
68788-9683-6ATORVASTATIN CALCIUM60 in 1 BOTTLETABLET, FILM COATED604
68788-9683-9ATORVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9683ATORVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4Legacy NDC, 4 package rows20170506_7ba5c4ab-e385-4803-9a5c-ea7eafad550f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617310atorvastatin calcium 20 MG Oral TabletPSN7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617311atorvastatin calcium 40 MG Oral TabletPSN7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617312atorvastatin 10 MG Oral TabletSCD7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617310atorvastatin 20 MG Oral TabletSCD7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617311atorvastatin 40 MG Oral TabletSCD7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY7ba5c4ab-e385-4803-9a5c-ea7eafad550f4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY7ba5c4ab-e385-4803-9a5c-ea7eafad550f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9683-168788968301100 in 1 BOTTLEHistorical
68788-9683-36878896830330 in 1 BOTTLEHistorical
68788-9683-66878896830660 in 1 BOTTLEHistorical
68788-9683-96878896830990 in 1 BOTTLEHistorical