ZOMIG
These highlights do not include all the information needed to use ZOMIG Nasal Spray safely and effectively. See full prescribing information for ZOMIG Nasal Spray.ZOMIG (zolmitriptan) nasal sprayInitial U.S. Approval: 1997
Approved
Approval ID
84b51cb9-83f3-4a49-7fa3-1adc0f963658
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2019
Manufacturers
FDA
Amneal Pharmaceuticals
DUNS: 123797875
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 Code64896-682
Application NumberNDA021450
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationNASAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ZOLMITRIPTANActive
Quantity: 2.5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
NITROGENInactive
Code: N762921K75
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-681
Application NumberNDA021450
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationNASAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (5)
ZOLMITRIPTANActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT