ZOMIG
These highlights do not include all the information needed to use ZOMIG or ZOMIG-ZMT safely and effectively. See full prescribing information for ZOMIG or ZOMIG-ZMT.ZOMIG (zolmitriptan) tablets, for oral useZOMIG-ZMT (zolmitriptan), Orally Disintegrating TabletsInitial U.S. Approval: 1997
Approved
Approval ID
df93b636-103f-4fb5-26b6-50f639e29b1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2019
Manufacturers
FDA
Amneal Pharmaceuticals
DUNS: 123797875
Products 4
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 Code64896-692
Application NumberNDA021231
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
ZOLMITRIPTANActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-672
Application NumberNDA020768
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (10)
ZOLMITRIPTANActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-671
Application NumberNDA020768
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (11)
ZOLMITRIPTANActive
Quantity: 2.5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64896-691
Application NumberNDA021231
Product Classification
M
Marketing Category
C73594
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2019
FDA Product Classification
INGREDIENTS (10)
ZOLMITRIPTANActive
Quantity: 2.5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT