ATORVASTATIN CALCIUM
These 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
Approved
Approval ID
2b5f69aa-2dd9-4eb8-b8b8-def1a1ec1433
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 26, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATORVASTATIN CALCIUM
PRODUCT DETAILS
NDC Product Code42254-307
Application NumberNDA020702
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateSeptember 25, 2012
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (13)
ATORVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CANDELILLA WAXInactive
Code: WL0328HX19
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT