Home NDC 24201-463 Dihydroergotamine Mesylate
Product NDC 24201-463
11-digit product format 242010463
Labeler code 24201
Product ID 24201-463_d9b07b6a-d574-4490-8294-8727e7a004af
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dihydroergotamine Mesylate
Dosage form SPRAY
Route NASAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA211393
Marketing category ANDA
Marketing start 2020-04-14
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 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 A211393-001 DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2020-02-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211393-001 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 2026-08-01 22:54:32 2026-06 A211393-001 DIHYDROERGOTAMINE MESYLATE 0.5MG/SPRAY SPRAY, METERED / NASAL AB 2020-02-28 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A211393-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Dihydroergotamine Mesylate
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 · 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 24201-463-08 Dihydroergotamine Mesylate 1 mL in 1 VIAL SPRAY 1 8 24201-463-08 Dihydroergotamine Mesylate 8 in 1 CARTON SPRAY 8 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24201-463 DIHYDROERGOTAMINE MESYLATE SPRAY [HIKMA PHARMACEUTICALS USA INC.] 7 Current NDC, Legacy NDC, 2 package rows 20241228_9ffe6d5a-7348-0498-e053-2a95a90a97a8.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 24201-463-01 24201046301 1 VIAL in 1 KIT (24201-463-01) > 1 mL in 1 VIAL 1 vial 2020-04-14 0000-00-00 No No Current 24201-463-08 24201046308 8 VIAL in 1 CARTON (24201-463-08) / 1 mL in 1 VIAL 8 vial 2020-04-14 0000-00-00 No No Current