zolmitriptan

Product NDC
63629-9575
11-digit product format
636299575
Labeler code
63629
Product ID
63629-9575_bf2b9204-93fa-4b0c-80a7-79e4aad901f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolmitriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA212469
Marketing category
ANDA
Marketing start
2021-11-16
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
Rxcui402000

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
63629-9575-1zolmitriptan6 in 1 CARTONSPRAY6106
63629-9575-2zolmitriptan1 in 1 BOTTLE, SPRAYSPRAY1106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9575ZOLMITRIPTAN SPRAY [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240816_8b4e77de-3185-4d1e-946a-96b785b76da0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSN8b4e77de-3185-4d1e-946a-96b785b76da0106
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCD8b4e77de-3185-4d1e-946a-96b785b76da0106
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySY8b4e77de-3185-4d1e-946a-96b785b76da0106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9575-1636299575016 BOTTLE, SPRAY in 1 CARTON (63629-9575-1) / 1 SPRAY in 1 BOTTLE, SPRAY (63629-9575-2) 2022-12-210000-00-00NoNoCurrent
63629-9575-2636299575021 in 1 BOTTLE, SPRAYHistorical