FDA.reportPublic FDA data

Epoprostenol for Injection

Manufacturer
Sun Pharmaceutical Industries, Inc. | Pharmalucence, Inc.
Effective date
2020-07-13
Label type
Human Prescription Drug Label
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:09:13

Label at a glance#

Productepoprostenol
Active ingredientEPOPROSTENOL SODIUM
Label structure4 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 mg-label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Unapproved
NDC 62756-175-40
Epoprostenol for Injection
0.5 mg (500,000 ng)/vial
For Intravenous Infusion Only
Sterile, Lyophilized Product
10 mL Single-dose Vial
Discard Unused Portion
Rx only
Sun Pharma

epoprostenol-0-5-ng-label
epoprostenol-0-5-ng-label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 ng Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Unapproved
NDC 62756-175-40
Epoprostenol for Injection
0.5 mg (500,000 ng)/vial
For Intravenous Infusion Only
Sterile, Lyophilized Product
1 x 10 mL Single-dose Vial
Discard Unused Portion

Rx only
Sun Pharma
epoprostenol-0-5-ng-cartonepoprostenol-0-5-ng-carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.5 ng Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unapproved
NDC 62756-176-40
Epoprostenol for Injection
1.5 mg (1,500,000 ng)/vial
For Intravenous Infusion Only
Sterile, Lyophilized Product
10 mL Single-dose Vial
Discard Unused Portion
Rx only
Sun Pharma

epoprostenol-1-5-ng-label
epoprostenol-1-5-ng-label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.5 ng Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Unapproved
NDC 62756-176-40
Epoprostenol for Injection
1.5 mg (1,500,000 ng)/vial
For Intravenous Infusion Only
Sterile, Lyophilized Product
1 x 10 mL Single-dose Vial
Discard Unused Portion
Rx only
Sun Pharma
epoprostenol-1-5-ng-cartonepoprostenol-1-5-ng-carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62756-17562756-175-40
62756-17662756-176-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPOPROSTENOL SODIUM4K04IQ1OF4ACTIM
SUCROSEC151H8M554IACT
GLYCINETE7660XO1CIACT
SODIUM HYDROXIDE55X04QC32IIACT
EPOPROSTENOL SODIUM4K04IQ1OF4ACTIM
SUCROSEC151H8M554IACT
GLYCINETE7660XO1CIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
552bc0c8-3255-4bec-98d1-9c36579c6f9ed5fea1b5-69df-45a7-9753-a2f77eaa4cfd2021-01-29Exact identifier
spl set id: d5fea1b5-69df-45a7-9753-a2f77eaa4cfd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.