FDA.reportPublic FDA data

SUMATRIPTAN

Product NDC
61919-300
11-digit product format
619190300
Labeler code
61919
Product ID
61919-300_ad3968a1-6821-4889-9ed5-a4057eb3a65c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sumatriptan succinate tablet
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078327
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
SUMATRIPTAN SUCCINATE
Active strength
100 mg/1
Pharmacologic classes
Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-300-092020-01-31C16284748780-19d75b9d0-79a5-f424-e053-dadaa90a57ceSUMATRIPTAN - sumatriptan succinate tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-300-09SUMATRIPTAN9 in 1 BLISTER PACKTABLET92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-300-09EA - Each61919-300acef96f2-384d-4ee1-aa35-9119fc2fa39812019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SUMATRIPTAN SUCCINATEACTIVE INGREDIENTJ8BDZ68989SUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
SUMATRIPTANACTIVE MOIETY8R78F6L9VOSUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HSUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-300SUMATRIPTAN (SUMATRIPTAN SUCCINATE TABLET) TABLET [DIRECT RX]2Legacy NDC, 1 package rows20150814_2abc46d5-1810-469d-8d31-fafa7312421c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313160SUMAtriptan succinate 100 MG Oral TabletPSN2abc46d5-1810-469d-8d31-fafa7312421c2
313160sumatriptan 100 MG Oral TabletSCD2abc46d5-1810-469d-8d31-fafa7312421c2
313160sumatriptan 100 MG (as sumatriptan succinate 140 MG) Oral TabletSY2abc46d5-1810-469d-8d31-fafa7312421c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-300-09619190300099 in 1 BLISTER PACKHistorical