FDA.reportPublic FDA data

Zolmitriptan

Product NDC
46708-182
11-digit product format
467080182
Labeler code
46708
Product ID
46708-182_052016e5-acea-4d2a-8d76-cef36eb99262
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA205074
Marketing category
ANDA
Marketing start
2016-12-01
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-182-132023-02-01C16284748780-1f386c649-cd26-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS. ZOLMITRIPTAN orally disintegrating tablets Initial U.S. Approval: 1997
46708-182-132023-01-30C16284748780-1f386c649-cd26-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for ZOLMITRIPTAN ORALLY DISINTEGRATING TABLETS. ZOLMITRIPTAN orally disintegrating tablets Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-182-03Zolmitriptan3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING34
46708-182-03Zolmitriptan3 in 1 CARTONTABLET, ORALLY DISINTEGRATING34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-182ZOLMITRIPTAN TABLET, ORALLY DISINTEGRATING [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 2 package rows20240224_b8d657ac-dbda-4455-8bb5-3896951c3b67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284201ZOLMitriptan 2.5 MG Disintegrating Oral TabletPSNb8d657ac-dbda-4455-8bb5-3896951c3b674
351134ZOLMitriptan 5 MG Disintegrating Oral TabletPSNb8d657ac-dbda-4455-8bb5-3896951c3b674
284201zolmitriptan 2.5 MG Disintegrating Oral TabletSCDb8d657ac-dbda-4455-8bb5-3896951c3b674
351134zolmitriptan 5 MG Disintegrating Oral TabletSCDb8d657ac-dbda-4455-8bb5-3896951c3b674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-182-03467080182033 BLISTER PACK in 1 CARTON (46708-182-03) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2016-12-01NoNoCurrent
46708-182-13467080182133 BLISTER PACK in 1 CARTON (46708-182-13) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2016-12-010000-00-00NoNoCurrent