Atorvastatin Calcium

Product NDC
53808-1008
11-digit product format
538081008
Labeler code
53808
Product ID
53808-1008_76954f50-9eb3-4b27-a0a9-13cb5f023e14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atorvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA091650
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
ATORVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1008-1Atorvastatin Calcium30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUMACTIVE INGREDIENT48A5M73Z4QATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHYLENE CHLORIDEINACTIVE INGREDIENT588X2YUY0AATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1008ATORVASTATIN CALCIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20141219_f12f81e5-634d-480c-b607-53ec5cbad03f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617310atorvastatin calcium 20 MG Oral TabletPSNf12f81e5-634d-480c-b607-53ec5cbad03f1
617311atorvastatin calcium 40 MG Oral TabletPSNf12f81e5-634d-480c-b607-53ec5cbad03f1
617310atorvastatin 20 MG Oral TabletSCDf12f81e5-634d-480c-b607-53ec5cbad03f1
617311atorvastatin 40 MG Oral TabletSCDf12f81e5-634d-480c-b607-53ec5cbad03f1
617310atorvastatin (as atorvastatin calcium) 20 MG Oral TabletSYf12f81e5-634d-480c-b607-53ec5cbad03f1
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSYf12f81e5-634d-480c-b607-53ec5cbad03f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1008-15380810080130 in 1 BLISTER PACKHistorical