FDA.reportPublic FDA data

Zolmitriptan

Product NDC
68382-715
11-digit product format
683820715
Labeler code
68382
Product ID
68382-715_c8bbe1ff-34e4-4638-ac8a-00b1ceb2f310
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
68382-715-01Zolmitriptan100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1008
68382-715-06Zolmitriptan30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING308
68382-715-10Zolmitriptan1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10008
68382-715-16Zolmitriptan90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING908
68382-715-30Zolmitriptan10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108
68382-715-69Zolmitriptan6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING68
68382-715-77Zolmitriptan10 in 1 CARTONTABLET, ORALLY DISINTEGRATING108
68382-715-86Zolmitriptan1 in 1 CARTONTABLET, ORALLY DISINTEGRATING18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-715-69EA - Each68382-715e1f8c5bb-1ca2-43d7-8ea7-939f3ae62f2812013-06-04
68382-715-86EA - Each68382-715414ce252-cb94-4f7c-bd5b-f306f25224f412013-06-04

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-715ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ZYDUS PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 8 package rows20231110_7fc95729-2f5d-4d5c-b26c-3a13854f73e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSN7fc95729-2f5d-4d5c-b26c-3a13854f73e38
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSN7fc95729-2f5d-4d5c-b26c-3a13854f73e38
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCD7fc95729-2f5d-4d5c-b26c-3a13854f73e38
351134zolmitriptan 5 MG Disintegrating Oral TabletSCD7fc95729-2f5d-4d5c-b26c-3a13854f73e38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-715-0168382071501100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-01) 2013-05-160000-00-00NoNoCurrent
68382-715-066838207150630 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-06) 2013-05-160000-00-00NoNoCurrent
68382-715-10683820715101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-10) 2013-05-160000-00-00NoNoCurrent
68382-715-166838207151690 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68382-715-16) 2013-05-160000-00-00NoNoCurrent
68382-715-306838207153010 in 1 BLISTER PACKHistorical
68382-715-69683820715696 in 1 BLISTER PACKHistorical
68382-715-776838207157710 BLISTER PACK in 1 CARTON (68382-715-77) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-30) 10 blister pack2013-05-160000-00-00NoNoCurrent
68382-715-86683820715861 BLISTER PACK in 1 CARTON (68382-715-86) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68382-715-69) 1 blister pack2013-05-160000-00-00NoNoCurrent