Sumatriptan

Product NDC
69097-644
11-digit product format
690970644
Labeler code
69097
Product ID
69097-644_7426a8de-8412-4aee-a320-f30097e37f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
SPRAY
Route
NASAL
Labeler
Cipla USA Inc.
Application
ANDA214209
Marketing category
ANDA
Marketing start
2021-02-22
Substance
SUMATRIPTAN
Active strength
20 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
SUMATRIPTAN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8R78F6L9VO
Rxcui314227

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-644-48Sumatriptan6 in 1 BOXSPRAY63
69097-644-48Sumatriptan1 in 1 CONTAINERSPRAY13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-644-48EA - Each69097-644cf9d8db4-f4cb-44d5-8517-611144be527412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-644SUMATRIPTAN SPRAY [CIPLA USA INC.]1Current NDC, Legacy NDC, 2 package rows20210224_559cca31-c0d2-45bf-999d-e92fc49a4a89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314227SUMAtriptan 20 MG/ACTUAT Nasal SprayPSN559cca31-c0d2-45bf-999d-e92fc49a4a893
314227sumatriptan 20 MG/ACTUAT Nasal SpraySCD559cca31-c0d2-45bf-999d-e92fc49a4a893
314227sumatriptan 20 MG/0.1 ML Nasal SpraySY559cca31-c0d2-45bf-999d-e92fc49a4a893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-644-48690970644486 CONTAINER in 1 BOX (69097-644-48) / 1 SPRAY in 1 CONTAINER6 container2021-02-220000-00-00NoNoCurrent