FDA.reportPublic FDA data

EPOPROSTENOL

Product NDC
67457-587
11-digit product format
674570587
Labeler code
67457
Product ID
67457-587_2a163b77-9e01-4516-b19c-f5a12ce48560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPOPROSTENOL
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA213913
Marketing category
ANDA
Marketing start
2024-09-25
Substance
EPOPROSTENOL
Active strength
.5 mg/10mL
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EPOPROSTENOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPOPROSTENOL.5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDCR9Z582X0
Rxcui562501, 562502

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ace20f6-48a7-4990-9c4c-3bbf62d1c730Product name220250225
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0b0b571c-056a-da12-12a1-e68fb540bb38Product name120140508
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-587-10EPOPROSTENOL10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,101
67457-587-10EPOPROSTENOL1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-587-10EA - Each67457-587714ee51d-8f9a-4eaf-9e9b-c2f372a6d96c12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-587EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]1Current NDC, 2 package rows20241004_2a163b77-9e01-4516-b19c-f5a12ce48560.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562501epoprostenol 0.5 MG InjectionPSN2a163b77-9e01-4516-b19c-f5a12ce485601
562502epoprostenol 1.5 MG InjectionPSN2a163b77-9e01-4516-b19c-f5a12ce485601
562501epoprostenol 0.5 MG InjectionSCD2a163b77-9e01-4516-b19c-f5a12ce485601
562502epoprostenol 1.5 MG InjectionSCD2a163b77-9e01-4516-b19c-f5a12ce485601
562501epoprostenol 0.5 MG (as epoprostenol sodium) InjectionSY2a163b77-9e01-4516-b19c-f5a12ce485601
562502epoprostenol 1.5 MG (as epoprostenol sodium) InjectionSY2a163b77-9e01-4516-b19c-f5a12ce485601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67457-587-10674570587101 VIAL in 1 CARTON (67457-587-10) / 10 mL in 1 VIAL1 vial2024-09-25NoNoHistorical