FDA.reportPublic FDA data

Sumatriptan

Product NDC
0527-1859
11-digit product format
005271859
Labeler code
0527
Product ID
0527-1859_1fca524e-6cf5-4782-b5d5-b37b101cd93a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Lannett Company, Inc.
Application
ANDA204841
Marketing category
ANDA
Marketing start
2016-02-19
Substance
SUMATRIPTAN
Active strength
20 mg/.1mL
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
Sumatriptan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SUMATRIPTAN20 mg/.1mL

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1859-432024-01-30C16284748780-11030e365-0b33-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use SUMATRIPTAN Nasal Spray, USP safely and effectively. See full prescribing information for SUMATRIPTAN Nasal Spray, USP . SUMATRIPTAN Nasal Spray, USP Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1859-43Sumatriptan6 in 1 CARTONSPRAY626
0527-1859-43Sumatriptan0.1 mL in 1 BLISTER PACKSPRAY0.126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1859-43EA - Each0527-1859b0465706-befd-4850-a3a0-a449ffeb8a6112016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1859SUMATRIPTAN SPRAY [LANNETT COMPANY, INC.]26Current NDC, Legacy NDC, 2 package rows20240704_64efe12a-cc43-47e6-b3dc-21dab6ddae06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314227SUMAtriptan 20 MG/ACTUAT Nasal SprayPSN64efe12a-cc43-47e6-b3dc-21dab6ddae0626
313159SUMAtriptan 5 MG/ACTUAT Nasal SprayPSN64efe12a-cc43-47e6-b3dc-21dab6ddae0626
314227sumatriptan 20 MG/ACTUAT Nasal SpraySCD64efe12a-cc43-47e6-b3dc-21dab6ddae0626
313159sumatriptan 5 MG/ACTUAT Nasal SpraySCD64efe12a-cc43-47e6-b3dc-21dab6ddae0626
314227sumatriptan 20 MG/0.1 ML Nasal SpraySY64efe12a-cc43-47e6-b3dc-21dab6ddae0626
313159sumatriptan 5 MG/0.1 ML Nasal SpraySY64efe12a-cc43-47e6-b3dc-21dab6ddae0626

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1859-43005271859436 BLISTER PACK in 1 CARTON (0527-1859-43) / .1 mL in 1 BLISTER PACK6 blister pack2016-02-190000-00-00NoNoCurrent