FDA.reportPublic FDA data

zolmitriptan

Product NDC
72162-1425
11-digit product format
721621425
Labeler code
72162
Product ID
72162-1425_0beab896-668c-44fe-bc69-3d0f7837cd1e
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
72162-1425-2zolmitriptan6 in 1 CARTONSPRAY6100
72162-1425-4zolmitriptan1 in 1 BOTTLE, SPRAYSPRAY1100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1425-2EA - Each72162-1425289b0199-d94c-4229-87d9-4b0375b8fb0712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1425ZOLMITRIPTAN SPRAY [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20250406_e304c986-24fa-451e-a560-0af658ba387b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSNe304c986-24fa-451e-a560-0af658ba387b100
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCDe304c986-24fa-451e-a560-0af658ba387b100
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySYe304c986-24fa-451e-a560-0af658ba387b100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1425-2721621425026 BOTTLE, SPRAY in 1 CARTON (72162-1425-2) / 1 SPRAY in 1 BOTTLE, SPRAY (72162-1425-4) 2025-04-03NoNoCurrent
72162-1425-4721621425041 in 1 BOTTLE, SPRAYHistorical