FDA.reportPublic FDA data

Sumatriptan

Product NDC
69452-345
11-digit product format
694520345
Labeler code
69452
Product ID
69452-345_44354d31-8bcb-491f-8e45-859337c6ca35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sumatriptan
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA078284
Marketing category
ANDA
Marketing start
2022-02-18
Substance
SUMATRIPTAN SUCCINATE
Active strength
50 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 SUCCINATE50 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
69452-345-60Sumatriptan9 in 1 BLISTER PACKTABLET, FILM COATED94
69452-345-72Sumatriptan1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-345-60EA - Each69452-3453fe09d34-7df6-4b89-9d90-0f57916810c112022-09-12
69452-345-72EA - Each69452-345a59fd390-ba5c-46c9-835d-0640b866193112022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-345SUMATRIPTAN TABLET, FILM COATED [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20231209_e90b0eea-c424-4f00-98da-6ed6e80de1f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSNe90b0eea-c424-4f00-98da-6ed6e80de1f65
315223SUMAtriptan succinate 25 MG Oral TabletPSNe90b0eea-c424-4f00-98da-6ed6e80de1f65
313161SUMAtriptan succinate 50 MG Oral TabletPSNe90b0eea-c424-4f00-98da-6ed6e80de1f65
313160sumatriptan 100 MG Oral TabletSCDe90b0eea-c424-4f00-98da-6ed6e80de1f65
315223sumatriptan 25 MG Oral TabletSCDe90b0eea-c424-4f00-98da-6ed6e80de1f65
313161sumatriptan 50 MG Oral TabletSCDe90b0eea-c424-4f00-98da-6ed6e80de1f65
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSYe90b0eea-c424-4f00-98da-6ed6e80de1f65
315223sumatriptan 25 MG (as sumatriptan succinate 35 MG) Oral TabletSYe90b0eea-c424-4f00-98da-6ed6e80de1f65
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSYe90b0eea-c424-4f00-98da-6ed6e80de1f65
313161SUMAtriptan succinate 50 MG Oral TabletPSN082d05f6-3850-0fa2-e063-6294a90a0c662
313161SUMAtriptan succinate 50 MG Oral TabletPSN0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2
313161sumatriptan 50 MG Oral TabletSCD0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2
313161sumatriptan 50 MG Oral TabletSCD082d05f6-3850-0fa2-e063-6294a90a0c662
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY0b9a0ab5-d8bd-4cae-b86c-45740ee1015a2
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY082d05f6-3850-0fa2-e063-6294a90a0c662
313161SUMAtriptan succinate 50 MG Oral TabletPSN85bf8e58-0984-427b-9ed4-7e0df4e444d21
313161SUMAtriptan succinate 50 MG Oral TabletPSN2aab8786-b225-833a-e063-6394a90ac7ae1
313161sumatriptan 50 MG Oral TabletSCD85bf8e58-0984-427b-9ed4-7e0df4e444d21
313161sumatriptan 50 MG Oral TabletSCD2aab8786-b225-833a-e063-6394a90ac7ae1
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY85bf8e58-0984-427b-9ed4-7e0df4e444d21
313161sumatriptan 50 MG (as sumatriptan succinate 70 MG) Oral TabletSY2aab8786-b225-833a-e063-6394a90ac7ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-345-60694520345609 in 1 BLISTER PACKHistorical
69452-345-72694520345721 BLISTER PACK in 1 CARTON (69452-345-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-345-60) 1 blister pack2022-02-180000-00-00NoNoCurrent