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
6d4c636f-9721-4b48-8840-12a1de593489
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 5, 2020
Manufacturers
FDA
CELLTRION USA, INC.
DUNS: 116587378
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 Code72606-568
Application NumberANDA206973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2020
FDA Product Classification
INGREDIENTS (10)
ZOLMITRIPTANActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-567
Application NumberANDA206973
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2020
FDA Product Classification
INGREDIENTS (10)
ZOLMITRIPTANActive
Quantity: 2.5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT