Home NDC 68083-466 Dihydroergotamine Mesylate
Product NDC 68083-466
11-digit product format 680830466
Labeler code 68083
Product ID 68083-466_a1a6aeb0-fb61-46bf-8b3f-7ed1a9cc21ae
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dihydroergotamine Mesylate
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Gland Pharma Limited
Application ANDA215623
Marketing category ANDA
Marketing start 2023-08-18
Substance DIHYDROERGOTAMINE MESYLATE
Active strength 1 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 A215623-001 DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215623-001 AP
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 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215623-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2023-08-18 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 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 861672 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 68083-466-10 Dihydroergotamine Mesylate 1 mL in 1 AMPULE INJECTION 1 7 68083-466-10 Dihydroergotamine Mesylate 10 in 1 CARTON INJECTION 10 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-466 DIHYDROERGOTAMINE MESYLATE INJECTION [GLAND PHARMA LIMITED] 7 Current NDC, 2 package rows 20230823_07a9112c-8c04-4849-8cb3-9463f58731d2.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 Sample Exclude flag Status 68083-466-10 68083046610 10 AMPULE in 1 CARTON (68083-466-10) / 1 mL in 1 AMPULE 10 ampule 2023-08-18 No No Current