FDA.reportPublic FDA data

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

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2021-03-12 10:30 UTC2021-03A213650-001SUMATRIPTAN5MG/SPRAYSPRAY / NASALAB2020-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213650-001SUMATRIPTAN5MG/SPRAYSPRAY / NASALAB2020-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213650-001SUMATRIPTAN5MG/SPRAYSPRAY / NASALAB2020-09-21c0c555d07b60…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-03-12 10:30 UTC2021-03A213650-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213650-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213650-001AB1c0c555d07b60…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8R78F6L9VOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313159Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7a5deb9-5de4-4a70-bb87-a40084b46f48Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUMATRIPTANSUMATRIPTANBryant Ranch Prepackc7a5deb9-5de4-4a70-bb87-a40084b46f482023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213650
application number: ANDA213650
ndc (product): 63629-8701

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