NDC 62756-060

epoprostenol

Epoprostenol

epoprostenol is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Epoprostenol Sodium.

Product ID62756-060_4a908d55-af35-4d85-b188-37a7ffad2e71
NDC62756-060
Product TypeHuman Prescription Drug
Proprietary Nameepoprostenol
Generic NameEpoprostenol
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2021-01-16
Marketing CategoryANDA / ANDA
Application NumberANDA210473
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameEPOPROSTENOL SODIUM
Active Ingredient Strength2 mg/10mL
Pharm ClassesProstacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 62756-060-40

1 VIAL in 1 CARTON (62756-060-40) > 10 mL in 1 VIAL
Marketing Start Date2021-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-060-40 [62756006040]

epoprostenol INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA210473
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
EPOPROSTENOL SODIUM1.5 mg/10mL

Pharmacological Class

  • Prostacycline Vasodilator [EPC]
  • Prostaglandins I [CS]
  • Vasodilation [PE]

NDC Crossover Matching brand name "epoprostenol" or generic name "Epoprostenol"

NDCBrand NameGeneric Name
62756-059epoprostenolepoprostenol
62756-060epoprostenolepoprostenol
66215-402Veletriepoprostenol
66215-403Veletriepoprostenol

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