Lapatinib
These highlights do not include all the information needed to use lapatinib tablets safely and effectively. See full prescribing information for lapatinib tablets. LAPATINIB tablets, for oral use Initial U.S. Approval: 2007
Approved
Approval ID
50d0dd0c-7682-43d0-aa1b-ca26e9181aee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 9, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lapatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-801
Application NumberANDA203007
Product Classification
M
Marketing Category
C73584
G
Generic Name
lapatinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 9, 2023
FDA Product Classification
INGREDIENTS (14)
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LAPATINIB DITOSYLATEActive
Quantity: 250 mg in 1 1
Code: G873GX646R
Classification: ACTIM
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT