FDA.reportPublic FDA data

Dihydroergotamine Mesylate

Product NDC
71357-013
11-digit product format
713570013
Labeler code
71357
Product ID
71357-013_52ba951e-772f-ca73-e063-6294a90a5fd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine Mesylate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Milla Pharmaceuticals Inc.
Application
ANDA212046
Marketing category
ANDA
Marketing start
2021-09-30
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
1 mg/mL
Pharmacologic classes
Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dihydroergotamine Mesylate
Listing expiration
2027-12-31

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
71357-013-01Dihydroergotamine Mesylate1 mL in 1 AMPULEINJECTION, SOLUTION12
71357-013-05Dihydroergotamine Mesylate5 in 1 CARTONINJECTION, SOLUTION52
71357-013-10Dihydroergotamine Mesylate10 in 1 CARTONINJECTION, SOLUTION102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861672dihydroergotamine mesylate 1 MG in 1 ML InjectionPSNb464a64d-b150-4f6b-b3df-e486a41294d72
8616721 ML dihydroergotamine mesylate 1 MG/ML InjectionSCDb464a64d-b150-4f6b-b3df-e486a41294d72
8616721 ML DHE Mesylate 1 MG/ML InjectionSYb464a64d-b150-4f6b-b3df-e486a41294d72
861672dihydroergotamine mesylate 1 MG per 1 ML InjectionSYb464a64d-b150-4f6b-b3df-e486a41294d72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71357-013-01713570013011 mL in 1 AMPULE1 mlHistorical
71357-013-05713570013055 AMPULE in 1 CARTON (71357-013-05) / 1 mL in 1 AMPULE (71357-013-01) 5 ampule2026-05-22NoNoCurrent
71357-013-107135700131010 AMPULE in 1 CARTON (71357-013-10) / 1 mL in 1 AMPULE (71357-013-01) 10 ampule2026-05-22NoNoCurrent