FDA.reportPublic FDA data

Zolmitriptan

Product NDC
65841-767
11-digit product format
658410767
Labeler code
65841
Product ID
65841-767_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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-767-01Zolmitriptan100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1006
65841-767-06Zolmitriptan30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING306
65841-767-10Zolmitriptan1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10006
65841-767-16Zolmitriptan90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING906
65841-767-30Zolmitriptan10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING106
65841-767-69Zolmitriptan6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING66
65841-767-77Zolmitriptan10 in 1 CARTONTABLET, ORALLY DISINTEGRATING106
65841-767-86Zolmitriptan1 in 1 CARTONTABLET, ORALLY DISINTEGRATING16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZOLMITRIPTANACTIVE INGREDIENT2FS66TH3YWZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ZOLMITRIPTANACTIVE MOIETY2FS66TH3YWZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
ORANGEINACTIVE INGREDIENT5EVU04N5QUZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [CADILA HEALTHCARE LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-767ZOLMITRIPTAN 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
65841-767-0165841076701100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-01) 2013-05-160000-00-00NoNoCurrent
65841-767-066584107670630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-06) 2013-05-160000-00-00NoNoCurrent
65841-767-10658410767101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-10) 2013-05-160000-00-00NoNoCurrent
65841-767-166584107671690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-16) 2013-05-160000-00-00NoNoCurrent
65841-767-306584107673010 in 1 BLISTER PACKHistorical
65841-767-69658410767696 in 1 BLISTER PACKHistorical
65841-767-776584107677710 BLISTER PACK in 1 CARTON (65841-767-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-767-30) 10 blister pack2013-05-160000-00-00NoNoCurrent
65841-767-86658410767861 BLISTER PACK in 1 CARTON (65841-767-86) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65841-767-69) 1 blister pack2013-05-160000-00-00NoNoCurrent