FDA.reportPublic FDA data

Zolmitriptan OD

Product NDC
59746-462
11-digit product format
597460462
Labeler code
59746
Product ID
59746-462_5d9c2d59-8564-44d8-bd79-0e0b34ec50bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Jubilant Cadista Pharmacuticals Inc.
Application
ANDA202956
Marketing category
ANDA
Marketing start
2015-09-17
Substance
ZOLMITRIPTAN
Active strength
5 mg/1
Pharmacologic classes
Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan OD
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLMITRIPTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FS66TH3YW
Rxcui284201, 351134

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
49286735-675f-7ca8-3815-48cfc7bb5a5aProduct name920180828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59746-462-132024-12-18C16284748780-1f386c649-ded9-0266-e053-dadaa90a7c1aThese 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
59746-462-132024-12-18C16284748780-1f386c649-ded9-0266-e053-dadaa90a7c1aThese 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
59746-462-132023-01-30C16284748780-1f386c649-ded9-0266-e053-dadaa90a7c1aThese 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
59746-462-132023-01-30C16284748780-1f386c649-ded9-0266-e053-dadaa90a7c1aThese 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59746-462-13Zolmitriptan OD1 in 1 CARTONTABLET, ORALLY DISINTEGRATING17
59746-462-13Zolmitriptan OD3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59746-462-13EA - Each59746-46296ad6f15-3f5d-4882-b44e-32736f83645f12017-06-15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZolmitriptanACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
ZolmitriptanACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Acesulfame PotassiumINACTIVE INGREDIENT23OV73Q5G9ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
CrospovidoneINACTIVE INGREDIENT68401960MKZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Dimethylaminoethyl Methacrylate - Butyl Methacrylate - Methyl Methacrylate CopolymerINACTIVE INGREDIENT905HNO1SIHZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Hydroxypropyl Cellulose (type H)INACTIVE INGREDIENTRFW2ET671PZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium Aluminometasilicate Type I-aINACTIVE INGREDIENT7LVU907546ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium Aluminum Silicate Type IaINACTIVE INGREDIENTSUS08ZOA9SZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Magnesium StearateINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
MannitolINACTIVE INGREDIENT3OWL53L36AZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
PeppermintINACTIVE INGREDIENTV95R5KMY2BZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3
TalcINACTIVE INGREDIENT7SEV7J4R1UZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-462ZOLMITRIPTAN OD (ZOLMITRIPTAN) TABLET, ORALLY DISINTEGRATING [JUBILANT CADISTA PHARMACUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20241220_a6a32fc6-4243-9cdd-91c7-b8a58e0f9811.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSNa6a32fc6-4243-9cdd-91c7-b8a58e0f98117
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSNa6a32fc6-4243-9cdd-91c7-b8a58e0f98117
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCDa6a32fc6-4243-9cdd-91c7-b8a58e0f98117
351134zolmitriptan 5 MG Disintegrating Oral TabletSCDa6a32fc6-4243-9cdd-91c7-b8a58e0f98117

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59746-462-13597460462131 BLISTER PACK in 1 CARTON (59746-462-13) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2015-09-170000-00-00NoNoCurrent