zolmitriptan

Product NDC
45802-711
11-digit product format
458020711
Labeler code
45802
Product ID
45802-711_670da414-66ad-4c5f-b218-f4958daae12c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
zolmitriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a0fbe307-6e31-a71d-5232-3216747b9b34Product name220220316
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
45802-711-00zolmitriptan1 in 1 BOTTLE, SPRAYSPRAY13
45802-711-91zolmitriptan6 in 1 CARTONSPRAY63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-711ZOLMITRIPTAN SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 2 package rows20231107_24e12658-eb42-4d1f-9192-9c4298416d51.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
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSN7a6924da-37a0-4e43-b57d-410b5179361b100
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSNe304c986-24fa-451e-a560-0af658ba387b100
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCD7a6924da-37a0-4e43-b57d-410b5179361b100
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCDe304c986-24fa-451e-a560-0af658ba387b100
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySY7a6924da-37a0-4e43-b57d-410b5179361b100
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySYe304c986-24fa-451e-a560-0af658ba387b100
402000ZOLMitriptan 5 MG/ACTUAT Nasal SprayPSN24e12658-eb42-4d1f-9192-9c4298416d513
402000zolmitriptan 5 MG/ACTUAT Nasal SpraySCD24e12658-eb42-4d1f-9192-9c4298416d513
402000zolmitriptan 5 MG/0.1 ML Nasal SpraySY24e12658-eb42-4d1f-9192-9c4298416d513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-711-00458020711001 in 1 BOTTLE, SPRAYHistorical
45802-711-91458020711916 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00) 2021-11-160000-00-00NoNoCurrent