FDA.reportPublic FDA data

Zolmitriptan

Product NDC
65841-768
11-digit product format
658410768
Labeler code
65841
Product ID
65841-768_31419037-52ae-41bb-a03e-8965205ab347
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA202890
Marketing category
ANDA
Marketing start
2013-05-16
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-768-01Zolmitriptan100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1006
65841-768-06Zolmitriptan30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING306
65841-768-10Zolmitriptan1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10006
65841-768-16Zolmitriptan90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING906
65841-768-30Zolmitriptan10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
65841-768-77Zolmitriptan10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
65841-768-82Zolmitriptan1 in 1 CARTONTABLET, ORALLY DISINTEGRATING16
65841-768-87Zolmitriptan3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-768ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 8 package rows20240817_aae2d9cb-9938-4032-961f-f0afd1958b5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSNaae2d9cb-9938-4032-961f-f0afd1958b5d6
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSNaae2d9cb-9938-4032-961f-f0afd1958b5d6
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCDaae2d9cb-9938-4032-961f-f0afd1958b5d6
351134zolmitriptan 5 MG Disintegrating Oral TabletSCDaae2d9cb-9938-4032-961f-f0afd1958b5d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-768-0165841076801100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-01) 2013-05-160000-00-00NoNoCurrent
65841-768-066584107680630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-06) 2013-05-160000-00-00NoNoCurrent
65841-768-10658410768101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-10) 2013-05-160000-00-00NoNoCurrent
65841-768-166584107681690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-768-16) 2013-05-160000-00-00NoNoCurrent
65841-768-306584107683010 in 1 BLISTER PACKHistorical
65841-768-776584107687710 BLISTER PACK in 1 CARTON (65841-768-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-30) 10 blister pack2013-05-160000-00-00NoNoCurrent
65841-768-82658410768821 BLISTER PACK in 1 CARTON (65841-768-82) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-768-87) 1 blister pack2013-05-160000-00-00NoNoCurrent
65841-768-87658410768873 in 1 BLISTER PACKHistorical