Naratriptan
These highlights do not include all the information needed to use NARATRIPTAN TABLETS safely and effectively. See full prescribing information for NARATRIPTAN TABLETS. NARATRIPTAN tablets, for oral useInitial U.S. Approval: 1998
Approved
Approval ID
fd1944b3-8054-4faa-a82e-d818dfdd3875
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 3, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naratriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0279
Application NumberANDA090381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naratriptan
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2020
FDA Product Classification
INGREDIENTS (6)
NARATRIPTAN HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 10X8X4P12Z
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Naratriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0278
Application NumberANDA090381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naratriptan
Product Specifications
Route of AdministrationORAL
Effective DateApril 1, 2020
FDA Product Classification
INGREDIENTS (6)
NARATRIPTAN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 10X8X4P12Z
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT