Relpax
These highlights do not include all the information needed to use RELPAX safely and effectively. See full prescribing information for RELPAX. RELPAX® (eletriptan hydrobromide) tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
85745375-fcb6-4edc-b6db-a77b4a5f3e8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 11, 2020
Manufacturers
FDA
ROERIG
DUNS: 829076996
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 Code0049-2330
Application NumberNDA021016
Product Classification
M
Marketing Category
C73594
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2020
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ELETRIPTAN HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
eletriptan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-2340
Application NumberNDA021016
Product Classification
M
Marketing Category
C73594
G
Generic Name
eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2020
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ELETRIPTAN HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT