FDA.reportPublic FDA data

epoprostenol

Product NDC
62756-059
11-digit product format
627560059
Labeler code
62756
Product ID
62756-059_fae129b5-c1b5-45f2-864c-eee72f289334
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epoprostenol
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA210473
Marketing category
ANDA
Marketing start
2021-01-16
Substance
EPOPROSTENOL SODIUM
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 SODIUM.5 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4K04IQ1OF4
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62756-059-402021-01-16C16284748780-19d75b9d0-6e80-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EPOPROSTENOL FOR INJECTION safely and effectively. See full prescribing information for EPOPROSTENOL FOR INJECTION. EPOPROSTENOL for injection, for intravenous use Initial U.S. Approval: 1995
62756-059-402020-01-31C16284748780-19d75b9d0-6e80-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EPOPROSTENOL FOR INJECTION safely and effectively. See full prescribing information for EPOPROSTENOL FOR INJECTION. EPOPROSTENOL for injection, for intravenous use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-059-40epoprostenol10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,106
62756-059-40epoprostenol1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-059-40EA - Each62756-0592e27d209-c314-49f3-b951-e651f122c97b12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-059EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 2 package rows20250425_db57e498-db20-45e8-8298-b0cf0811d270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562501epoprostenol 0.5 MG InjectionPSNdb57e498-db20-45e8-8298-b0cf0811d2706
562502epoprostenol 1.5 MG InjectionPSNdb57e498-db20-45e8-8298-b0cf0811d2706
562501epoprostenol 0.5 MG InjectionSCDdb57e498-db20-45e8-8298-b0cf0811d2706
562502epoprostenol 1.5 MG InjectionSCDdb57e498-db20-45e8-8298-b0cf0811d2706
562501epoprostenol 0.5 MG (as epoprostenol sodium) InjectionSYdb57e498-db20-45e8-8298-b0cf0811d2706
562502epoprostenol 1.5 MG (as epoprostenol sodium) InjectionSYdb57e498-db20-45e8-8298-b0cf0811d2706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-059-40627560059401 VIAL in 1 CARTON (62756-059-40) / 10 mL in 1 VIAL1 vial2021-01-160000-00-00NoNoCurrent