FDA.reportPublic FDA data

Sumavel DosePro

Product NDC
43376-106
11-digit product format
433760106
Labeler code
43376
Product ID
43376-106_5c36c308-b26d-492d-b923-80f600727c8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Zogenix, Inc.
Application
NDA022239
Marketing category
NDA
Marketing start
2009-07-15
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
6 mg/.5mL
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43376-106-012019-11-27C16284748780-19855e2a2-331b-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
43376-106-062019-11-27C16284748780-19855e2a2-331b-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
43376-106-512019-11-27C16284748780-19855e2a2-331b-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992
43376-106-542019-11-27C16284748780-19855e2a2-331b-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use Sumavel DosePro safely and effectively. See full prescribing information for Sumavel DosePro. Sumavel DosePro (sumatriptan injection), for subcutaneous use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43376-106-01Sumavel DosePro0.5 mL in 1 SYRINGE, GLASSINJECTION0.513
43376-106-01Sumavel DosePro1 in 1 CARTONINJECTION113
43376-106-06Sumavel DosePro0.5 mL in 1 SYRINGE, GLASSINJECTION0.513
43376-106-06Sumavel DosePro6 in 1 CARTONINJECTION613
43376-106-51Sumavel DosePro1 in 1 CARTONINJECTION113
43376-106-51Sumavel DosePro0.5 mL in 1 SYRINGE, GLASSINJECTION0.513
43376-106-54Sumavel DosePro4 in 1 CARTONINJECTION413
43376-106-54Sumavel DosePro0.5 mL in 1 SYRINGE, GLASSINJECTION0.513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43376-106SUMAVEL DOSEPRO (SUMATRIPTAN) INJECTION [ZOGENIX, INC.]13Legacy NDC, 8 package rows20140212_6a4c0c2f-497d-4c5c-84c4-9ab42780cbde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1657178SUMAtriptan 4 MG in 0.5 ML Jet InjectorPSN6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1657167SUMAtriptan 6 MG in 0.5 ML Jet InjectorPSN6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1484927Sumavel 4 MG in 0.5 ML Jet InjectorPSN6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
856789Sumavel 6 MG in 0.5 ML Jet InjectorPSN6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
8567890.5 ML sumatriptan 12 MG/ML Jet Injector [Sumavel]SBD6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
14849270.5 ML sumatriptan 8 MG/ML Jet Injector [Sumavel]SBD6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
16571670.5 ML sumatriptan 12 MG/ML Jet InjectorSCD6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
16571780.5 ML sumatriptan 8 MG/ML Jet InjectorSCD6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
8567890.5 ML Sumavel 12 MG/ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
14849270.5 ML Sumavel 8 MG/ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1657178sumatriptan (as sumatriptan succinate) 4 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1657167sumatriptan (as sumatriptan succinate) 6 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1657178sumatriptan 4 MG per 0.5 ML Needle-Free Drug Delivery SystemSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1657167sumatriptan 6 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1657167sumatriptan 6 MG per 0.5 ML Needle-Free Drug Delivery SystemSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1484927Sumavel (as sumatriptan succinate) 4 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
856789Sumavel (as sumatriptan succinate) 6 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1484927Sumavel 4 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
856789Sumavel 6 MG per 0.5 ML Jet InjectorSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
1484927Sumavel DosePro 4 MG per 0.5 ML Needle-Free Drug Delivery SystemSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13
856789Sumavel DosePro 6 MG per 0.5 ML Needle-Free Drug Delivery SystemSY6a4c0c2f-497d-4c5c-84c4-9ab42780cbde13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
43376-106-01433760106010.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
43376-106-06433760106060.5 mL in 1 SYRINGE, GLASS0.5 mlHistorical
43376-106-51433760106511 in 1 CARTONHistorical
43376-106-54433760106544 in 1 CARTONHistorical