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
e0dfeb1f-f0f0-449a-81ae-2c8fdddcff10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2023
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code68382-923
Application NumberANDA206409
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (13)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ELETRIPTAN HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Eletriptan hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68382-922
Application NumberANDA206409
Product Classification
M
Marketing Category
C73584
G
Generic Name
Eletriptan hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2023
FDA Product Classification
INGREDIENTS (13)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
ELETRIPTAN HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: M41W832TA3
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT