LETROZOLE
These highlights do not include all the information needed to use letrozole safely and effectively. See full prescribing information for letrozole tablets. Letrozole Tablets, USP Initial U.S. Approval: 1997
Approved
Approval ID
b73bf908-7979-4955-af20-0414388920da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 9, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
letrozole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6252
Application NumberANDA078190
Product Classification
M
Marketing Category
C73584
G
Generic Name
letrozole
Product Specifications
Route of AdministrationORAL
Effective DateMay 9, 2011
FDA Product Classification
INGREDIENTS (16)
LETROZOLEActive
Quantity: 2.5 mg in 1 1
Code: 7LKK855W8I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT