Home NDC 68682-357 Dihydroergotamine Mesylate
Product NDC 68682-357
11-digit product format 686820357
Labeler code 68682
Product ID 68682-357_2fb28487-fdba-28d9-e063-6394a90a1b4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dihydroergotamine mesylate
Dosage form SPRAY
Route NASAL
Labeler Oceanside Pharmaceuticals
Application NDA020148
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-03-18
Marketing end 2027-06-30
Substance DIHYDROERGOTAMINE MESYLATE
Active strength 4 mg/mL
Pharmacologic classes Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag No
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 N020148-001 MIGRANAL DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020148-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL RLD, RS 1997-12-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020148-001 MIGRANAL 0.5MG/SPRAY SPRAY, METERED / NASAL AB RLD, RS 1997-12-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Dihydroergotamine Mesylate Active Ingredients# Ingredient, Strength table Ingredient Strength DIHYDROERGOTAMINE MESYLATE 4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 81AXN7R2QT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861668 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 68682-357-10 Dihydroergotamine Mesylate 1 mL in 1 VIAL SPRAY 1 8 68682-357-10 Dihydroergotamine Mesylate 8 in 1 KIT SPRAY 8 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-357 DIHYDROERGOTAMINE MESYLATE SPRAY [OCEANSIDE PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 2 package rows 20250309_977de209-c53a-4cb4-9f3f-1e850600a9dc.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 68682-357-10 68682035710 8 VIAL in 1 KIT (68682-357-10) / 1 mL in 1 VIAL 8 vial 2013-03-18 2027-06-30 No No Current