Tarceva
These highlights do not include all the information needed to use TARCEVA safely and effectively. See full prescribing information for TARCEVA. TARCEVA (erlotinib hydrochloride) tablet for oral use Initial U.S. Approval: 2004
Approved
Approval ID
5783976b-0862-44e5-9b19-0f41d236d5c3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
erlotinib hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5290
Application NumberNDA021743
Product Classification
M
Marketing Category
C73594
G
Generic Name
erlotinib hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
erlotinib hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5474
Application NumberNDA021743
Product Classification
M
Marketing Category
C73594
G
Generic Name
erlotinib hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
erlotinib hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5447
Application NumberNDA021743
Product Classification
M
Marketing Category
C73594
G
Generic Name
erlotinib hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (9)
ERLOTINIB HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT