Onzetra Xsail

Product NDC
42847-311
11-digit product format
428470311
Labeler code
42847
Product ID
42847-311_1b32d254-9be1-4601-9a8c-a039d4cd5a01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate
Dosage form
CAPSULE
Route
NASAL
Labeler
Currax Pharmaceuticals LLC
Application
NDA206099
Marketing category
NDA
Marketing start
2015-10-01
Substance
SUMATRIPTAN SUCCINATE
Active strength
11 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
Onzetra Xsail
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN SUCCINATE11 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui1739332, 1739337

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
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
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42847-311-08Onzetra Xsail8 in 1 CARTONCAPSULE84
42847-311-08Onzetra Xsail2 in 1 POUCHCAPSULE24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42847-311-08EA - Each42847-311cefe8261-7872-481f-bbe7-7179d204901a12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42847-311ONZETRA XSAIL (SUMATRIPTAN SUCCINATE) CAPSULE [CURRAX PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20240423_a8a9889e-69b9-4a57-b8c0-d40b1025c559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1739337ONZETRA Xsail 11 MG Nasal PowderPSNa8a9889e-69b9-4a57-b8c0-d40b1025c5594
1739332SUMAtriptan 11 MG Nasal PowderPSNa8a9889e-69b9-4a57-b8c0-d40b1025c5594
1739337sumatriptan 11 MG Nasal Powder [Onzetra]SBDa8a9889e-69b9-4a57-b8c0-d40b1025c5594
1739332sumatriptan 11 MG Nasal PowderSCDa8a9889e-69b9-4a57-b8c0-d40b1025c5594
1739337Onzetra 11 MG Nasal PowderSYa8a9889e-69b9-4a57-b8c0-d40b1025c5594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42847-311-08428470311088 POUCH in 1 CARTON (42847-311-08) / 2 CAPSULE in 1 POUCH8 pouch2015-10-010000-00-00NoNoCurrent