Dihydroergotamine Mesylate

Product NDC
81284-411
11-digit product format
812840411
Labeler code
81284
Product ID
81284-411_c3c6ccb7-6054-426c-8a56-d3c29dac13e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine Mesylate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Provepharm 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
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
81284-411-00Dihydroergotamine Mesylate1 mL in 1 AMPULEINJECTION, SOLUTION15
81284-411-05Dihydroergotamine Mesylate5 in 1 CARTONINJECTION, SOLUTION55
81284-411-10Dihydroergotamine Mesylate10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81284-411-00ML - Milliliter81284-411808c7794-961a-4579-8994-9c7648f1975a12022-06-06
81284-411-05ML - Milliliter81284-4119f5c28eb-c0c4-4cfe-aa58-fe92298d3b7212022-11-07
81284-411-10ML - Milliliter81284-411f78fdc46-fb48-493d-8b42-538ed279fe4512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81284-411DIHYDROERGOTAMINE MESYLATE INJECTION, SOLUTION [PROVEPHARM INC.]5Current NDC, Legacy NDC, 3 package rows20250227_40b9ba9e-436e-444e-b078-01b12bb57ea7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861672dihydroergotamine mesylate 1 MG in 1 ML InjectionPSN40b9ba9e-436e-444e-b078-01b12bb57ea75
8616721 ML dihydroergotamine mesylate 1 MG/ML InjectionSCD40b9ba9e-436e-444e-b078-01b12bb57ea75
8616721 ML DHE Mesylate 1 MG/ML InjectionSY40b9ba9e-436e-444e-b078-01b12bb57ea75
861672dihydroergotamine mesylate 1 MG per 1 ML InjectionSY40b9ba9e-436e-444e-b078-01b12bb57ea75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81284-411-00812840411001 mL in 1 AMPULE1 mlHistorical
81284-411-05812840411055 AMPULE in 1 CARTON (81284-411-05) / 1 mL in 1 AMPULE (81284-411-00) 5 ampule2021-09-300000-00-00NoNoCurrent
81284-411-108128404111010 AMPULE in 1 CARTON (81284-411-10) / 1 mL in 1 AMPULE (81284-411-00) 10 ampule2021-09-300000-00-00NoNoCurrent