ATORVASTATIN CALCIUM

Product NDC
53808-1035
11-digit product format
538081035
Labeler code
53808
Product ID
53808-1035_68e4fb9f-b9e8-4411-9631-1dd26bc40975
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATORVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA090548
Marketing category
ANDA
Marketing start
2014-01-01
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
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1035-1ATORVASTATIN CALCIUM30 in 1 BLISTER PACKTABLET, FILM COATED302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1035ATORVASTATIN CALCIUM TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20141103_587a3c44-92a0-4455-a07b-cf6ca33a594d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
617312atorvastatin calcium 10 MG Oral TabletPSN587a3c44-92a0-4455-a07b-cf6ca33a594d2
617311atorvastatin calcium 40 MG Oral TabletPSN587a3c44-92a0-4455-a07b-cf6ca33a594d2
617312atorvastatin 10 MG Oral TabletSCD587a3c44-92a0-4455-a07b-cf6ca33a594d2
617311atorvastatin 40 MG Oral TabletSCD587a3c44-92a0-4455-a07b-cf6ca33a594d2
617312atorvastatin (as atorvastatin calcium) 10 MG Oral TabletSY587a3c44-92a0-4455-a07b-cf6ca33a594d2
617311atorvastatin (as atorvastatin calcium) 40 MG Oral TabletSY587a3c44-92a0-4455-a07b-cf6ca33a594d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1035-15380810350130 in 1 BLISTER PACKHistorical