Dromelate

Product NDC
70529-030
11-digit product format
705290030
Labeler code
70529
Product ID
70529-030_15b2b0cd-f103-4d3a-b8d7-18456cb3dfde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine Mesylate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
IT3 Medical LLC
Application
ANDA040475
Marketing category
ANDA
Marketing start
2017-03-01
Marketing end
0000-00-00
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
1 mg/mL
Pharmacologic classes
Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70529-030-012023-07-28C16284748780-1d6a99b39-6c0c-a426-e053-dadaa90af4c2Dromelate Injection System
70529-030-012022-03-01C16284748780-1d6a99b39-6c0c-a426-e053-dadaa90af4c2Dromelate Injection System
70529-030-012022-01-28C16284748780-1d6a99b39-6c0c-a426-e053-dadaa90af4c2Dromelate Injection System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70529-030-01Dromelate1 mL in 1 AMPULEINJECTION, SOLUTION13
70529-030-01Dromelate1 in 1 PACKAGEINJECTION, SOLUTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70529-030DROMELATE (DIHYDROERGOTAMINE MESYLATE) INJECTION, SOLUTION [IT3 MEDICAL LLC]3Legacy NDC, 2 package rows20220302_2367e853-1109-4c23-a177-6829304832e8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861672dihydroergotamine mesylate 1 MG in 1 ML InjectionPSN2367e853-1109-4c23-a177-6829304832e83
8616721 ML dihydroergotamine mesylate 1 MG/ML InjectionSCD2367e853-1109-4c23-a177-6829304832e83
8616721 ML DHE Mesylate 1 MG/ML InjectionSY2367e853-1109-4c23-a177-6829304832e83
861672dihydroergotamine mesylate 1 MG per 1 ML InjectionSY2367e853-1109-4c23-a177-6829304832e83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70529-030-01705290030011 AMPULE in 1 PACKAGE (70529-030-01) > 1 mL in 1 AMPULE1 ampule2017-03-010000-00-00NoNoCurrent