FDA.reportPublic FDA data

SUMATRIPTAN

Product NDC
45802-619
11-digit product format
458020619
Labeler code
45802
Product ID
45802-619_d1aeb8e8-e726-405a-bf9d-7436af66c48b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA213465
Marketing category
ANDA
Marketing start
2020-10-04
Substance
SUMATRIPTAN
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUMATRIPTAN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8R78F6L9VO
Rxcui313159, 314227

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-619-00SUMATRIPTAN1 in 1 CONTAINERSPRAY19
45802-619-06SUMATRIPTAN6 in 1 CARTONSPRAY69
45802-619-00SUMATRIPTAN1 in 1 CONTAINERSPRAY11
45802-619-06SUMATRIPTAN6 in 1 CARTONSPRAY61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-619SUMATRIPTAN SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 2 package rows20240921_6d521807-e5ce-498d-a224-5534c5ea61fa.zip
45802-619SUMATRIPTAN SPRAY [PERRIGO NEW YORK INC]1Current NDC, Legacy NDC, 2 package rows20201004_22a7ef1d-f505-4fbb-9fe1-9e34e3e2a266.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313159SUMAtriptan 5 MG/ACTUAT Nasal SprayPSNc7a5deb9-5de4-4a70-bb87-a40084b46f48102
313159sumatriptan 5 MG/ACTUAT Nasal SpraySCDc7a5deb9-5de4-4a70-bb87-a40084b46f48102
313159sumatriptan 5 MG/0.1 ML Nasal SpraySYc7a5deb9-5de4-4a70-bb87-a40084b46f48102
314227SUMAtriptan 20 MG/ACTUAT Nasal SprayPSN6d521807-e5ce-498d-a224-5534c5ea61fa9
313159SUMAtriptan 5 MG/ACTUAT Nasal SprayPSN6d521807-e5ce-498d-a224-5534c5ea61fa9
314227sumatriptan 20 MG/ACTUAT Nasal SpraySCD6d521807-e5ce-498d-a224-5534c5ea61fa9
313159sumatriptan 5 MG/ACTUAT Nasal SpraySCD6d521807-e5ce-498d-a224-5534c5ea61fa9
314227sumatriptan 20 MG/0.1 ML Nasal SpraySY6d521807-e5ce-498d-a224-5534c5ea61fa9
313159sumatriptan 5 MG/0.1 ML Nasal SpraySY6d521807-e5ce-498d-a224-5534c5ea61fa9
313159SUMAtriptan 5 MG/ACTUAT Nasal SprayPSN22a7ef1d-f505-4fbb-9fe1-9e34e3e2a2661
313159sumatriptan 5 MG/ACTUAT Nasal SpraySCD22a7ef1d-f505-4fbb-9fe1-9e34e3e2a2661
313159sumatriptan 5 MG/0.1 ML Nasal SpraySY22a7ef1d-f505-4fbb-9fe1-9e34e3e2a2661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-619-00458020619001 in 1 CONTAINERHistorical
45802-619-06458020619066 CONTAINER in 1 CARTON (45802-619-06) / 1 SPRAY in 1 CONTAINER (45802-619-00) 6 container2020-10-040000-00-00NoNoCurrent