Home NDC 63629-8703 SUMATRIPTAN
Product NDC 63629-8703
11-digit product format 636298703
Labeler code 63629
Product ID 63629-8703_58d27c3f-feb7-46fb-b427-8286f923a2be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan
Dosage form SPRAY
Route NASAL
Labeler Bryant Ranch Prepack
Application ANDA213465
Marketing category ANDA
Marketing start 2020-10-04
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213465-001 SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 A213465-002 SUMATRIPTAN SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 2 · 73 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213465-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2020-09-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213465-002 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2020-09-21 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 73 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SUMATRIPTAN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SUMATRIPTAN 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8R78F6L9VO Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314227 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-8703-1 SUMATRIPTAN 6 in 1 CARTON SPRAY 6 104 63629-8703-1 SUMATRIPTAN 1 in 1 CONTAINER SPRAY 1 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8703 SUMATRIPTAN SPRAY [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 2 package rows 20230718_7328ab4f-2985-448d-8724-8f1b55693b41.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8703-1 63629870301 6 CONTAINER in 1 CARTON (63629-8703-1) / 1 SPRAY in 1 CONTAINER 6 container 2020-10-04 0000-00-00 No No Current