Home NDC 0527-1859 Sumatriptan
Product NDC 0527-1859
11-digit product format 005271859
Labeler code 0527
Product ID 0527-1859_1fca524e-6cf5-4782-b5d5-b37b101cd93a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sumatriptan
Dosage form SPRAY
Route NASAL
Labeler Lannett Company, Inc.
Application ANDA204841
Marketing category ANDA
Marketing start 2016-02-19
Substance SUMATRIPTAN
Active strength 20 mg/.1mL
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 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 A204841-001 SUMATRIPTAN SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 A204841-002 SUMATRIPTAN SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19
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 3 · 84 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 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204841-001 SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB 2016-02-19 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204841-002 SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB 2016-02-19 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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/.1mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313159 Internal RxNorm lookup 314227 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0527-1859-43 Sumatriptan 6 in 1 CARTON SPRAY 6 26 0527-1859-43 Sumatriptan 0.1 mL in 1 BLISTER PACK SPRAY 0.1 26
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1859 SUMATRIPTAN SPRAY [LANNETT COMPANY, INC.] 26 Current NDC, Legacy NDC, 2 package rows 20240704_64efe12a-cc43-47e6-b3dc-21dab6ddae06.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.
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 0527-1859-43 00527185943 6 BLISTER PACK in 1 CARTON (0527-1859-43) / .1 mL in 1 BLISTER PACK 6 blister pack 2016-02-19 0000-00-00 No No Current