Zolmitriptan OD

Product NDC
59746-461
11-digit product format
597460461
Labeler code
59746
Product ID
59746-461_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
2.5 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
ZOLMITRIPTAN2.5 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
59746-461-162024-12-18C16284748780-1f386c649-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
59746-461-162024-12-18C16284748780-1f386c649-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
59746-461-162023-01-30C16284748780-1f386c649-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
59746-461-162023-01-30C16284748780-1f386c649-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
59746-461-16Zolmitriptan OD2 in 1 CARTONTABLET, ORALLY DISINTEGRATING27
59746-461-16Zolmitriptan OD3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-461ZOLMITRIPTAN 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
59746-461-16597460461162 BLISTER PACK in 1 CARTON (59746-461-16) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2015-09-170000-00-00NoNoCurrent