FDA.reportPublic FDA data

Zolmitriptan

Product NDC
69238-2352
11-digit product format
692382352
Labeler code
69238
Product ID
69238-2352_3481678d-2990-4288-bec4-f402cad1b8d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Zolmitriptan
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
NDA021450
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-07-15
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
Rxcui1483677, 402000

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
49286735-675f-7ca8-3815-48cfc7bb5a5aProduct name920180828
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2352-6Zolmitriptan1 in 1 BOTTLE, SPRAYSPRAY, METERED15
69238-2352-6Zolmitriptan6 in 1 CARTONSPRAY, METERED65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2352ZOLMITRIPTAN SPRAY, METERED [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, 2 package rows20241121_05a40502-149d-41bd-966e-771e937a955b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1483677ZOLMitriptan 2.5 MG/ACTUAT Nasal SprayPSN05a40502-149d-41bd-966e-771e937a955b5
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSN05a40502-149d-41bd-966e-771e937a955b5
1483677zolmitriptan 2.5 MG/ACTUAT Nasal SpraySCD05a40502-149d-41bd-966e-771e937a955b5
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCD05a40502-149d-41bd-966e-771e937a955b5
1483677zolmitriptan 2.5 MG/0.1 ML Nasal SpraySY05a40502-149d-41bd-966e-771e937a955b5
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySY05a40502-149d-41bd-966e-771e937a955b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69238-2352-6692382352066 BOTTLE, SPRAY in 1 CARTON (69238-2352-6) / 1 SPRAY, METERED in 1 BOTTLE, SPRAY2024-07-15NoNoCurrent