SUMATRIPTAN

Product NDC
63629-8701
11-digit product format
636298701
Labeler code
63629
Product ID
63629-8701_08918eab-05d3-4d11-b013-4c6ee1835fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Bryant Ranch Prepack
Application
ANDA213650
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
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
SUMATRIPTAN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8R78F6L9VO
Rxcui313159

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
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
63629-8701-1SUMATRIPTAN6 in 1 CARTONSPRAY6102
63629-8701-1SUMATRIPTAN1 in 1 CONTAINERSPRAY1102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8701-1EA - Each63629-8701c345c436-0a38-4c42-b8d4-d2085b0a0ebd12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8701SUMATRIPTAN SPRAY [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 2 package rows20230718_c7a5deb9-5de4-4a70-bb87-a40084b46f48.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8701-1636298701016 CONTAINER in 1 CARTON (63629-8701-1) / 1 SPRAY in 1 CONTAINER6 container2021-07-210000-00-00NoNoCurrent