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
e36fa076-e23b-437f-bbd2-0433ce333175
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 6, 2019
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code63304-095
Application NumberANDA210300
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (10)
ERLOTINIBActive
Quantity: 25 mg in 1 1
Code: J4T82NDH7E
Classification: ACTIB
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-096
Application NumberANDA210300
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (10)
ERLOTINIBActive
Quantity: 100 mg in 1 1
Code: J4T82NDH7E
Classification: ACTIB
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Erlotinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-135
Application NumberANDA210300
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erlotinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2019
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ERLOTINIBActive
Quantity: 150 mg in 1 1
Code: J4T82NDH7E
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT