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

Additional Listing Data#

Finished product
Yes
Brand name base
dihydroergotamine mesylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIHYDROERGOTAMINE MESYLATE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81AXN7R2QT
Rxcui861672

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c9a995-456f-4920-9be6-19f388510405Product name120260303
0dc20644-8d0b-4adf-9269-872bb65fd7fbProduct name320251205
803e1b3a-35b6-0bc8-229b-d2f7e8a7ffd4Product name520250516
2053edd2-6ad3-4897-ba63-817235bdab3cProduct name220220309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36000-300-01dihydroergotamine mesylate1 mL in 1 AMPULEINJECTION, SOLUTION15
36000-300-10dihydroergotamine mesylate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-300DIHYDROERGOTAMINE MESYLATE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5Current NDC, 2 package rows20250112_f87dcd07-90ef-4e37-853e-7a5911a038b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861672dihydroergotamine mesylate 1 MG in 1 ML InjectionPSNf87dcd07-90ef-4e37-853e-7a5911a038b15
8616721 ML dihydroergotamine mesylate 1 MG/ML InjectionSCDf87dcd07-90ef-4e37-853e-7a5911a038b15
8616721 ML DHE Mesylate 1 MG/ML InjectionSYf87dcd07-90ef-4e37-853e-7a5911a038b15
861672dihydroergotamine mesylate 1 MG per 1 ML InjectionSYf87dcd07-90ef-4e37-853e-7a5911a038b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
36000-300-01360000300011 mL in 1 AMPULE1 mlHistorical
36000-300-103600003001010 AMPULE in 1 CARTON (36000-300-10) / 1 mL in 1 AMPULE (36000-300-01) 10 ampule2025-01-07NoNoHistorical