Zolmitriptan
These highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
75a92ce1-eade-4b71-80ab-d7fd1f57e352
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-463
Application NumberANDA204232
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZOLMITRIPTANActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-462
Application NumberANDA204232
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2023
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ZOLMITRIPTANActive
Quantity: 2.5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT