FDA.reportPublic FDA data

ATORVASTATIN CALCIUM

Product NDC
43353-827
11-digit product format
433530827
Labeler code
43353
Product ID
43353-827_cdb75f3a-bd50-4718-bdd3-0bd3cff8117f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA020702
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-11-30
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM TRIHYDRATE
Active strength
80 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
d25cba4b-d79e-4890-8837-1382f7d09489Product name120231002
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
43353-827-152023-01-30C16284748780-1f386c649-ca7b-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 administration Initial U.S. Approval: 1996
43353-827-302023-01-30C16284748780-1f386c649-ca7b-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 administration Initial U.S. Approval: 1996
43353-827-452023-01-30C16284748780-1f386c649-ca7b-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 administration Initial U.S. Approval: 1996
43353-827-532023-01-30C16284748780-1f386c649-ca7b-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 administration Initial U.S. Approval: 1996
43353-827-602023-01-30C16284748780-1f386c649-ca7b-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 administration Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-827-15ATORVASTATIN CALCIUM15 in 1 BOTTLE, PLASTICTABLET, FILM COATED154
43353-827-30ATORVASTATIN CALCIUM30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
43353-827-45ATORVASTATIN CALCIUM45 in 1 BOTTLE, PLASTICTABLET, FILM COATED454
43353-827-53ATORVASTATIN CALCIUM60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
43353-827-60ATORVASTATIN CALCIUM90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-827-15EA - Each43353-827f48e41cc-bdb2-4c2a-a40c-1505d1712d2112014-01-04
43353-827-30EA - Each43353-827ad12fd3b-0a95-47f4-a93a-c8910cc81f4812014-01-04
43353-827-45EA - Each43353-82786f62b19-6f7a-4e4e-8bcb-6d205df35f1a12014-01-04
43353-827-53EA - Each43353-8278ae57b17-1c2c-4012-91e0-21f5f4c6ebc112014-01-04
43353-827-60EA - Each43353-8275d8a98a5-aac2-445b-a24e-c872a073ead212014-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM TRIHYDRATEACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CANDELILLA WAXINACTIVE INGREDIENTWL0328HX19ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-827ATORVASTATIN CALCIUM TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC, 5 package rows20191221_1b1faadc-b8b5-4545-a12b-060a90881aec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSN1b1faadc-b8b5-4545-a12b-060a90881aec4
617311atorvastatin calcium 40 MG Oral TabletPSN1b1faadc-b8b5-4545-a12b-060a90881aec4
259255atorvastatin calcium 80 MG Oral TabletPSN1b1faadc-b8b5-4545-a12b-060a90881aec4
617310atorvastatin 20 MG Oral TabletSCD1b1faadc-b8b5-4545-a12b-060a90881aec4
617311atorvastatin 40 MG Oral TabletSCD1b1faadc-b8b5-4545-a12b-060a90881aec4
259255atorvastatin 80 MG Oral TabletSCD1b1faadc-b8b5-4545-a12b-060a90881aec4
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSY1b1faadc-b8b5-4545-a12b-060a90881aec4
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY1b1faadc-b8b5-4545-a12b-060a90881aec4
259255atorvastatin (as atorvastatin calcium) 80 MG Oral TabletSY1b1faadc-b8b5-4545-a12b-060a90881aec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-827-154335308271515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-15) 2013-03-110000-00-00NoNoCurrent
43353-827-304335308273030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-30) 2013-03-110000-00-00NoNoCurrent
43353-827-454335308274545 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-45) 2013-03-110000-00-00NoNoCurrent
43353-827-534335308275360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-53) 2013-03-110000-00-00NoNoCurrent
43353-827-604335308276090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43353-827-60) 2013-03-110000-00-00NoNoCurrent