Zolmitriptan

Product NDC
68462-497
11-digit product format
684620497
Labeler code
68462
Product ID
68462-497_742c4c1c-c601-4656-86c1-69021eb552c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc.,USA
Application
ANDA201779
Marketing category
ANDA
Marketing start
2013-05-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Zolmitriptan
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOLMITRIPTAN2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2FS66TH3YW
Rxcui200193, 200194

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
68462-497-40Zolmitriptan6 in 1 BLISTER PACKTABLET, FILM COATED614
68462-497-76Zolmitriptan1 in 1 CARTONTABLET, FILM COATED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-497ZOLMITRIPTAN TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA]13Current NDC, Legacy NDC, 2 package rows20240705_333caafc-2e63-49f8-a0c6-534e528d228d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSN333caafc-2e63-49f8-a0c6-534e528d228d14
200194ZOLMitriptan 5 MG Oral TabletPSN333caafc-2e63-49f8-a0c6-534e528d228d14
200193zolmitriptan 2.5 MG Oral TabletSCD333caafc-2e63-49f8-a0c6-534e528d228d14
200194zolmitriptan 5 MG Oral TabletSCD333caafc-2e63-49f8-a0c6-534e528d228d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-497-40684620497406 in 1 BLISTER PACKHistorical
68462-497-76684620497761 BLISTER PACK in 1 CARTON (68462-497-76) / 6 TABLET, FILM COATED in 1 BLISTER PACK (68462-497-40) 1 blister pack2013-05-140000-00-00NoNoCurrent