ZOMIG
These highlights do not include all the information needed to use ZOMIG NASAL SPRAY. See full prescribing information for ZOMIG (zolmitriptan) NASAL SPRAYINITIAL U.S. APPROVAL: 1997
Approved
Approval ID
f2073122-5138-41ba-b791-a9b088bb98b7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-955
Application NumberNDA021450
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationNASAL
Effective DateJune 8, 2010
FDA Product Classification
INGREDIENTS (5)
ZOLMITRIPTANActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
CITRIC ACID ANHYDROUSInactive
Code: XF417D3PSL
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT