FDA.reportPublic FDA data

Zolmitriptan

Product NDC
63548-0101
11-digit product format
635480101
Labeler code
63548
Product ID
63548-0101_bf9467df-5c81-4b04-8ca3-e3f9104132e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PLD Acquisitions LLC DBA Av�ma Pharma Solutions
Application
ANDA207867
Marketing category
ANDA
Marketing start
2017-02-27
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
63548-0101-62023-02-09C16284748780-1f386c64a-1a54-0266-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
63548-0101-62023-01-30C16284748780-1f386c64a-1a54-0266-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
63548-0101-6Zolmitriptan6 in 1 BLISTER PACKTABLET, FILM COATED68
63548-0101-6Zolmitriptan1 in 1 CARTONTABLET, FILM COATED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0101ZOLMITRIPTAN TABLET, FILM COATED [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20230210_f59bfbdd-7f4b-4a29-8396-e144dde65878.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSNf59bfbdd-7f4b-4a29-8396-e144dde658788
200194ZOLMitriptan 5 MG Oral TabletPSNf59bfbdd-7f4b-4a29-8396-e144dde658788
200193zolmitriptan 2.5 MG Oral TabletSCDf59bfbdd-7f4b-4a29-8396-e144dde658788
200194zolmitriptan 5 MG Oral TabletSCDf59bfbdd-7f4b-4a29-8396-e144dde658788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63548-0101-6635480101061 BLISTER PACK in 1 CARTON (63548-0101-6) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2017-02-270000-00-00NoNoCurrent