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 use Initial U.S. Approval: 1998
Approved
Approval ID
93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2023
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
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 Code69452-340
Application NumberANDA091441
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naratriptan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (8)
NARATRIPTAN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 10X8X4P12Z
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Naratriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-341
Application NumberANDA091441
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naratriptan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2023
FDA Product Classification
INGREDIENTS (10)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
NARATRIPTAN HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 10X8X4P12Z
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT