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 use Initial U.S. Approval: 2002
Approved
Approval ID
fd427d2d-b78b-412a-9c80-606bc88ad112
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2021
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-043
Application NumberANDA206787
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eletriptan Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2021
FDA Product Classification
INGREDIENTS (11)
ELETRIPTAN HYDROBROMIDE MONOHYDRATEActive
Quantity: 40 mg in 1 1
Code: 4139X692FA
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
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 Code65162-042
Application NumberANDA206787
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eletriptan Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2021
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ELETRIPTAN HYDROBROMIDE MONOHYDRATEActive
Quantity: 20 mg in 1 1
Code: 4139X692FA
Classification: ACTIM