Zolmitriptan OD
These highlights do not include all the information needed to use zolmitriptan orally disintegrating tablets safely and effectively. See full prescribing information for zolmitriptan orally disintegrating tablets. ZOLMITRIPTAN Orally Disintegrating Tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
a6a32fc6-4243-9cdd-91c7-b8a58e0f9811
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 18, 2015
Manufacturers
FDA
Jubilant Cadista Pharmaceuticals Inc.
DUNS: 022490515
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 Code59746-462
Application NumberANDA202956
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2019
FDA Product Classification
INGREDIENTS (12)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ZolmitriptanActive
Quantity: 5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
Magnesium Aluminum Silicate Type IaInactive
Code: SUS08ZOA9S
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT
Zolmitriptan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-461
Application NumberANDA202956
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zolmitriptan
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2019
FDA Product Classification
INGREDIENTS (12)
Magnesium Aluminometasilicate Type I-aInactive
Code: 7LVU907546
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ZolmitriptanActive
Quantity: 2.5 mg in 1 1
Code: 2FS66TH3YW
Classification: ACTIB
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerInactive
Code: 905HNO1SIH
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
MannitolInactive
Code: 3OWL53L36A
Classification: IACT
Crospovidone, UnspecifiedInactive
Code: 2S7830E561
Classification: IACT
Acesulfame PotassiumInactive
Code: 23OV73Q5G9
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
PeppermintInactive
Code: V95R5KMY2B
Classification: IACT