Home NDC 36000-300 dihydroergotamine mesylate
Product NDC 36000-300
11-digit product format 360000300
Labeler code 36000
Product ID 36000-300_f87dcd07-90ef-4e37-853e-7a5911a038b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dihydroergotamine mesylate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Baxter Healthcare Corporation
Application ANDA216747
Marketing category ANDA
Marketing start 2025-01-07
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 A216747-001 DIHYDROERGOTAMINE MESYLATE DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION 2025-01-07
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 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION 2025-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION 2025-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION 2025-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2025-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2025-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION AP 2025-01-07 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216747-001 DIHYDROERGOTAMINE MESYLATE 1MG/ML INJECTABLE / INJECTION 2025-01-07 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216747-001 AP 1 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216747-001 AP 1 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216747-001 AP 1 03ed91905a0d…
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 36000-300-01 dihydroergotamine mesylate 1 mL in 1 AMPULE INJECTION, SOLUTION 1 5 36000-300-10 dihydroergotamine mesylate 10 in 1 CARTON INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-300 DIHYDROERGOTAMINE MESYLATE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] 5 Current NDC, 2 package rows 20250112_f87dcd07-90ef-4e37-853e-7a5911a038b1.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 36000-300-01 36000030001 1 mL in 1 AMPULE 1 ml Historical 36000-300-10 36000030010 10 AMPULE in 1 CARTON (36000-300-10) / 1 mL in 1 AMPULE (36000-300-01) 10 ampule 2025-01-07 No No Current