FDA.reportPublic FDA data

Zolmitriptan

Product NDC
46708-462
11-digit product format
467080462
Labeler code
46708
Product ID
46708-462_edab3a0b-baf7-422c-be76-2638914d62f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA204232
Marketing category
ANDA
Marketing start
2016-01-04
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
Rxcui200193, 200194

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
46708-462-062023-02-01C16284748780-1f386c649-b6ff-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997
46708-462-062023-01-30C16284748780-1f386c649-b6ff-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLMITRIPTAN TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN TABLETS. ZOLMITRIPTAN tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-462-06Zolmitriptan6 in 1 CARTONTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-462ZOLMITRIPTAN TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 1 package rows20230202_75a92ce1-eade-4b71-80ab-d7fd1f57e352.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSN75a92ce1-eade-4b71-80ab-d7fd1f57e3523
200194ZOLMitriptan 5 MG Oral TabletPSN75a92ce1-eade-4b71-80ab-d7fd1f57e3523
200193zolmitriptan 2.5 MG Oral TabletSCD75a92ce1-eade-4b71-80ab-d7fd1f57e3523
200194zolmitriptan 5 MG Oral TabletSCD75a92ce1-eade-4b71-80ab-d7fd1f57e3523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-462-06467080462066 TABLET, FILM COATED in 1 CARTON (46708-462-06) 2016-01-040000-00-00NoNoCurrent