Dihydroergotamine Mesylate

Product NDC
0143-9151
11-digit product format
001439151
Labeler code
0143
Product ID
0143-9151_d2a5e902-dbcc-4e9e-9963-aba4568e2835
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine Mesylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040453
Marketing category
ANDA
Marketing start
2023-03-31
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
0143-9151-10Dihydroergotamine Mesylate1 mL in 1 VIALINJECTION11
0143-9151-10Dihydroergotamine Mesylate10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9151DIHYDROERGOTAMINE MESYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20230331_683ca944-efa7-4ca3-9cbe-cf0e7ffb1d64.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861672dihydroergotamine mesylate 1 MG in 1 ML InjectionPSN683ca944-efa7-4ca3-9cbe-cf0e7ffb1d641
8616721 ML dihydroergotamine mesylate 1 MG/ML InjectionSCD683ca944-efa7-4ca3-9cbe-cf0e7ffb1d641
8616721 ML DHE Mesylate 1 MG/ML InjectionSY683ca944-efa7-4ca3-9cbe-cf0e7ffb1d641
861672dihydroergotamine mesylate 1 MG per 1 ML InjectionSY683ca944-efa7-4ca3-9cbe-cf0e7ffb1d641

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9151-100014391511010 VIAL in 1 CARTON (0143-9151-10) / 1 mL in 1 VIAL10 vial2023-03-31NoNoHistorical