Home NDC 0781-6523 SUMATRIPTAN
Product NDC 0781-6523
11-digit product format 007816523
Labeler code 0781
Product ID 0781-6523_f9989be0-513c-4c19-a4cf-4069531895ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sumatriptan
Dosage form SPRAY
Route NASAL
Labeler Sandoz Inc
Application NDA020626
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2008-09-11
Marketing end 2022-01-31
Substance SUMATRIPTAN
Active strength 20 mg/100uL
Pharmacologic classes Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0781-6523-86 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0781-6523-86 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0781-6523-86 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0781-6523-86 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0781-6523-86 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0781-6523-86 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0781-6523-86 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0781-6523-86 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0781-6523-86 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0781-6523-86 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0781-6523-86 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0781-6523-86 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020626-001 IMITREX SUMATRIPTAN 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 N020626-002 IMITREX SUMATRIPTAN 10MG/SPRAY SPRAY / NASAL 1997-08-26 N020626-003 IMITREX SUMATRIPTAN 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26
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 4 · 126 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 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020626-002 IMITREX 10MG/SPRAY SPRAY / NASAL 1997-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020626-003 IMITREX 20MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020626-001 IMITREX 5MG/SPRAY SPRAY / NASAL AB RLD, RS 1997-08-26 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SUMATRIPTAN ACTIVE INGREDIENT 8R78F6L9VO SUMATRIPTAN SPRAY [SANDOZ INC] 9 SUMATRIPTAN ACTIVE MOIETY 8R78F6L9VO SUMATRIPTAN SPRAY [SANDOZ INC] 9 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 SUMATRIPTAN SPRAY [SANDOZ INC] 9 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SUMATRIPTAN SPRAY [SANDOZ INC] 9 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F SUMATRIPTAN SPRAY [SANDOZ INC] 9 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF SUMATRIPTAN SPRAY [SANDOZ INC] 9 WATER INACTIVE INGREDIENT 059QF0KO0R SUMATRIPTAN SPRAY [SANDOZ INC] 9 SUMATRIPTAN ACTIVE INGREDIENT 8R78F6L9VO SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2 SUMATRIPTAN ACTIVE MOIETY 8R78F6L9VO SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2 POTASSIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 4J9FJ0HL51 SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM PHOSPHATE, DIBASIC ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R SUMATRIPTAN SPRAY [PHYSICIANS TOTAL CARE, INC.] 2
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 0781-6523-86 00781652386 6 CONTAINER in 1 BOX (0781-6523-86) > 100 uL in 1 CONTAINER (0781-6523-06) 6 container 2008-09-11 0000-00-00 No No Current