FDA.reportPublic FDA data

Atorvastatin Calcium

Product NDC
54458-881
11-digit product format
544580881
Labeler code
54458
Product ID
54458-881_e8280f19-334f-465e-b67b-f8f5b6a4b9bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA090548
Marketing category
ANDA
Marketing start
2014-06-01
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
2020-12-31
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
54458-881-102022-01-28C16284748780-1d6a99b39-9f79-a426-e053-dadaa90af4c2These 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
54458-881-162022-01-28C16284748780-1d6a99b39-9f79-a426-e053-dadaa90af4c2These 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
54458-881-10Atorvastatin Calcium30 in 1 BLISTER PACKTABLET, FILM COATED3019
54458-881-16Atorvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-881-10EA - Each54458-881dcd66477-4263-4337-8646-793d0fcb8f8012014-07-02
54458-881-16EA - Each54458-881730b2bef-0090-4383-be69-f554b2635b9a12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-881ATORVASTATIN CALCIUM TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]19Legacy NDC, 2 package rows20191221_48b8ba97-a358-443a-b4e6-d087227ae26d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617311atorvastatin calcium 40 MG Oral TabletPSN48b8ba97-a358-443a-b4e6-d087227ae26d19
617311atorvastatin 40 MG Oral TabletSCD48b8ba97-a358-443a-b4e6-d087227ae26d19
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY48b8ba97-a358-443a-b4e6-d087227ae26d19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54458-881-105445808811030 TABLET, FILM COATED in 1 BLISTER PACK (54458-881-10) 2014-06-010000-00-00NoNoCurrent
54458-881-165445808811630 TABLET, FILM COATED in 1 BOTTLE (54458-881-16) 2017-05-220000-00-00NoNoCurrent