Epoprostenol for Injection

epoprostenol by

Drug Labeling and Warnings

epoprostenol by is a Prescription medication manufactured, distributed, or labeled by Sun Pharmaceutical Industries, Inc., Pharmalucence, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EPOPROSTENOL - epoprostenol injection, powder, lyophilized, for solution 
Sun Pharmaceutical Industries, Inc.

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Epoprostenol for Injection

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 mg-label


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.5 ng Carton


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-carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.5 ng Label

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1.5 ng Carton

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-carton

EPOPROSTENOL 
epoprostenol injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62756-175
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPOPROSTENOL SODIUM (UNII: 4K04IQ1OF4) (EPOPROSTENOL - UNII:DCR9Z582X0) EPOPROSTENOL0.5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
GLYCINE (UNII: TE7660XO1C)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62756-175-401 in 1 CARTON11/01/202001/29/2021
110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY11/01/202001/29/2021
EPOPROSTENOL 
epoprostenol injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62756-176
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPOPROSTENOL SODIUM (UNII: 4K04IQ1OF4) (EPOPROSTENOL - UNII:DCR9Z582X0) EPOPROSTENOL1.5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
SUCROSE (UNII: C151H8M554)  
GLYCINE (UNII: TE7660XO1C)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62756-176-401 in 1 CARTON11/01/202001/29/2021
110 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
EXPORT ONLY11/01/202001/29/2021
Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Pharmalucence, Inc.139261648ANALYSIS(62756-175, 62756-176) , LABEL(62756-175, 62756-176) , MANUFACTURE(62756-175, 62756-176) , PACK(62756-175, 62756-176)

Revised: 1/2021
Document Id: 552bc0c8-3255-4bec-98d1-9c36579c6f9e
Set id: d5fea1b5-69df-45a7-9753-a2f77eaa4cfd
Version: 2
Effective Time: 20210129