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
41c29652-32f8-48dc-9038-0e2195aa2084
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
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 Code23155-055
Application NumberANDA200502
Product Classification
M
Marketing Category
C73584
G
Generic Name
naratriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2021
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
NARATRIPTAN HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 10X8X4P12Z
Classification: ACTIM
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
naratriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-054
Application NumberANDA200502
Product Classification
M
Marketing Category
C73584
G
Generic Name
naratriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2021
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
NARATRIPTAN HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: 10X8X4P12Z
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT