Dihydroergotamine Mesylate

Product NDC
69238-1606
11-digit product format
692381606
Labeler code
69238
Product ID
69238-1606_ab344498-3127-4482-8e64-e586dd291307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dihydroergotamine
Dosage form
SPRAY
Route
NASAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214105
Marketing category
ANDA
Marketing start
2022-01-10
Marketing end
0000-00-00
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
4 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69238-1606-82026-01-15C16284748780-11030e365-10b3-111a-e063-dadaa90a10e252ebf4f0-c126-4439-a5e3-430fe90a3d28
69238-1606-82024-01-30C16284748780-11030e365-10b3-111a-e063-dadaa90a10e252ebf4f0-c126-4439-a5e3-430fe90a3d28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1606-1ML - Milliliter69238-160676e07d4e-713a-472c-9401-ef2cfc97e67c12023-10-16
69238-1606-8ML - Milliliter69238-16069ecc97ad-a49e-42fd-a8a3-4527c493d11f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1606DIHYDROERGOTAMINE MESYLATE (DIHYDROERGOTAMINE) SPRAY [AMNEAL PHARMACEUTICALS NY LLC]14Legacy NDC20221014_52ebf4f0-c126-4439-a5e3-430fe90a3d28.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1606-8692381606088 VIAL in 1 CARTON (69238-1606-8) > 1 mL in 1 VIAL (69238-1606-1) 8 vial2022-01-100000-00-00NoNoCurrent