Home NDC 77530-725 Trudhesa
Product NDC 77530-725
11-digit product format 775300725
Labeler code 77530
Product ID 77530-725_8118afb5-12dc-4dee-91e8-731286b0c1a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dihydroergotamine mesylate
Dosage form SPRAY, METERED
Route NASAL
Labeler Impel Pharmaceuticals LLC
Application NDA213436
Marketing category NDA
Marketing start 2021-09-24
Substance DIHYDROERGOTAMINE MESYLATE
Active strength 4 mg/mL
Pharmacologic classes Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 6 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 2025-01-20 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 77530-725-04 ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 77530-725-00 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 77530-725-04 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 77530-725-00 0efc9e666f02…f202fb6c5f17…
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 N213436-001 TRUDHESA DIHYDROERGOTAMINE MESYLATE 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213436-001 9550036 2032-09-05 Drug product 2021-09-30 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 N213436-001 11185497 2039-01-04 U-3218 2021-12-16
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 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213436-001 TRUDHESA 0.725MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2021-09-02 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 194 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213436-001 11185497 2039-01-04 U-3218 2021-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213436-001 11185497 2039-01-04 U-3218 2021-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213436-001 11185497 2039-01-04 U-3218 2021-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213436-001 11185497 2039-01-04 U-3218 2021-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213436-001 11185497 2039-01-04 U-3218 2021-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 11266799 2036-11-05 Drug product 2022-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213436-001 11185497 2039-01-04 U-3218 2021-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213436-001 9550036 2032-09-05 Drug product 2021-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213436-001 10507295 2032-12-25 Drug product 2021-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213436-001 10940278 2033-01-23 Drug product 2021-09-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213436-001 9919117 2033-03-17 U-3218 Drug product 2021-09-30 2680178bc6a6…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Trudhesa
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2569836 Internal RxNorm lookup 2569842 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 77530-725-00 Trudhesa 1 mL in 1 VIAL, GLASS SPRAY, METERED 1 6 77530-725-00 Trudhesa 1 in 1 CARTON SPRAY, METERED 1 6 77530-725-04 Trudhesa 1 mL in 1 VIAL, GLASS SPRAY, METERED 1 6 77530-725-04 Trudhesa 4 in 1 CARTON SPRAY, METERED 4 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77530-725 TRUDHESA (DIHYDROERGOTAMINE MESYLATE) SPRAY, METERED [IMPEL PHARMACEUTICALS LLC] 6 Current NDC, Legacy NDC, 4 package rows 20250125_b81397b0-910d-4eb4-8fee-a9a3c9d94d63.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trudhesa DIHYDROERGOTAMINE MESYLATE Impel Pharmaceuticals LLC b81397b0-910d-4eb4-8fee-a9a3c9d94d63 2025-01-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 213436 application number: NDA213436 ndc (product): 77530-725
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 77530-725-00 77530072500 1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS 2021-09-24 0000-00-00 Yes No Current 77530-725-04 77530072504 4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS 2021-09-24 0000-00-00 No No Current