Eletriptan Hydrobromide
These highlights do not include all the information needed to use ELETRIPTAN HYDROBROMIDE TABLETS safely and effectively. See full prescribing information for ELETRIPTAN HYDROBROMIDE TABLETS. ELETRIPTAN HYDROBROMIDE tablets, for oral useInitial U.S. Approval: 2002
Approved
Approval ID
20276f5c-f2d6-469f-9a1b-aa254a1db21c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2020
Manufacturers
FDA
Mylan Pharmaceuticals Inc.
DUNS: 059295980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
eletriptan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-4288
Application NumberANDA205152
Product Classification
M
Marketing Category
C73584
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2018
FDA Product Classification
INGREDIENTS (11)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ELETRIPTAN HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
eletriptan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0378-4287
Application NumberANDA205152
Product Classification
M
Marketing Category
C73584
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2018
FDA Product Classification
INGREDIENTS (11)
ELETRIPTAN HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT