Zolmitriptan

Product NDC
69097-863
11-digit product format
690970863
Labeler code
69097
Product ID
69097-863_dcf24dee-fe87-4adf-b572-16c08868a355
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA204284
Marketing category
ANDA
Marketing start
2016-07-20
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-863-17Zolmitriptan1 in 1 CARTONTABLET, FILM COATED13
69097-863-17Zolmitriptan6 in 1 BLISTER PACKTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-863ZOLMITRIPTAN TABLET, FILM COATED [CIPLA USA INC.]3Current NDC, Legacy NDC, 2 package rows20191105_16e520fe-2f57-400b-8ee5-9a3f89037d6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200193ZOLMitriptan 2.5 MG Oral TabletPSN16e520fe-2f57-400b-8ee5-9a3f89037d6c3
200194ZOLMitriptan 5 MG Oral TabletPSN16e520fe-2f57-400b-8ee5-9a3f89037d6c3
200193zolmitriptan 2.5 MG Oral TabletSCD16e520fe-2f57-400b-8ee5-9a3f89037d6c3
200194zolmitriptan 5 MG Oral TabletSCD16e520fe-2f57-400b-8ee5-9a3f89037d6c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-863-17690970863171 BLISTER PACK in 1 CARTON (69097-863-17) / 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-07-200000-00-00NoNoCurrent