Erlotinib
These highlights do not include all the information needed to use ERLOTINIB TABLETS safely and effectively. See full prescribing information for ERLOTINIB TABLETS. ERLOTINIB tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
3ecafc1e-979a-4aff-a276-18fc0b110491
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 6, 2022
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-531
Application NumberANDA216342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-530
Application NumberANDA216342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-532
Application NumberANDA216342
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 16, 2021
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ERLOTINIB HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: DA87705X9K
Classification: ACTIM
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT