FDA.reportPublic FDA data

Sumatriptan

Product NDC
16714-796
11-digit product format
167140796
Labeler code
16714
Product ID
16714-796_bbcead21-a14a-4f3a-acd4-6a49741d7b92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan Succinate
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078327
Marketing category
ANDA
Marketing start
2018-06-18
Substance
SUMATRIPTAN SUCCINATE
Active strength
25 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
SUMATRIPTAN SUCCINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ8BDZ68989
Rxcui313160, 313161, 315223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2Product name420250724
2839c963-7eb3-970a-287f-ff1b6d381268Product name220250103
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
1e973b2d-e028-69cd-9258-4613ba80fdc5Product name320210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
3eb481d3-8b69-436f-82dd-4a66345568abProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877cProduct name120160303
49615343-b619-4365-8118-8f2ed6046e78Product name120160224
a6319377-430a-43db-82f9-30d1d9d89cf8Product name120151216
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
f6199b09-e585-7ceb-4b09-803cf5ce1ed1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-796-01Sumatriptan1 in 1 CARTONTABLET15
16714-796-01Sumatriptan9 in 1 BLISTER PACKTABLET95

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-796-01EA - Each16714-796d3b0cd47-4f5f-451a-a469-1b5ed97c822412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-796SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 2 package rows20240131_84bfc4ba-4172-4adb-b963-4e0eb438c07a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN84bfc4ba-4172-4adb-b963-4e0eb438c07a5
315223SUMAtriptan succinate 25 MG Oral TabletPSN84bfc4ba-4172-4adb-b963-4e0eb438c07a5
313161SUMAtriptan succinate 50 MG Oral TabletPSN84bfc4ba-4172-4adb-b963-4e0eb438c07a5
313160sumatriptan 100 MG Oral TabletSCD84bfc4ba-4172-4adb-b963-4e0eb438c07a5
315223sumatriptan 25 MG Oral TabletSCD84bfc4ba-4172-4adb-b963-4e0eb438c07a5
313161sumatriptan 50 MG Oral TabletSCD84bfc4ba-4172-4adb-b963-4e0eb438c07a5
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY84bfc4ba-4172-4adb-b963-4e0eb438c07a5
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSY84bfc4ba-4172-4adb-b963-4e0eb438c07a5
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY84bfc4ba-4172-4adb-b963-4e0eb438c07a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-796-01167140796011 BLISTER PACK in 1 CARTON (16714-796-01) / 9 TABLET in 1 BLISTER PACK1 blister pack2018-06-180000-00-00NoNoCurrent