Home NDC 71921-170 Sumatriptan
Product NDC 71921-170
11-digit product format 719210170
Labeler code 71921
Product ID 71921-170_d0b56323-49ef-f239-e053-2a95a90ae766
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan
Dosage form SPRAY
Route NASAL
Labeler Florida Pharmaceutical Products, LLC.
Application ANDA208967
Marketing category ANDA
Marketing start 2021-05-15
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208967-001 SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208967-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208967-001 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2021-02-17 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Additional Listing Data#
Finished product Yes
Brand name base Sumatriptan
Listing expiration 2026-12-31 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 71921-170-61 Sumatriptan 1 in 1 CONTAINER SPRAY 1 2 71921-170-61 Sumatriptan 6 in 1 BOX SPRAY 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71921-170 SUMATRIPTAN SPRAY [FLORIDA PHARMACEUTICAL PRODUCTS, LLC.] 2 Current NDC, Legacy NDC, 2 package rows 20211123_267dadc1-6960-4d8b-88ef-86be9c5f7159.zip
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 71921-170-61 71921017061 6 CONTAINER in 1 BOX (71921-170-61) / 1 SPRAY in 1 CONTAINER 6 container 2021-05-15 0000-00-00 No No Current