NDC 0703-1995

Epoprostenol Sodium

Epoprostenol Sodium

Epoprostenol Sodium is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Epoprostenol Sodium.

Product ID0703-1995_1916c211-a026-4b81-9909-35962a9ae003
NDC0703-1995
Product TypeHuman Prescription Drug
Proprietary NameEpoprostenol Sodium
Generic NameEpoprostenol Sodium
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-04-23
Marketing CategoryANDA / ANDA
Application NumberANDA078396
Labeler NameTeva Parenteral Medicines, Inc.
Substance NameEPOPROSTENOL SODIUM
Active Ingredient Strength2 mg/1
Pharm ClassesProstacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0703-1995-01

1 VIAL in 1 CARTON (0703-1995-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
Marketing Start Date2008-04-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0703-1995-01 [00703199501]

Epoprostenol Sodium INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA078396
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2008-04-23

Drug Details

Active Ingredients

IngredientStrength
EPOPROSTENOL SODIUM1.5 mg/1

OpenFDA Data

SPL SET ID:56733651-d331-4e69-a6a3-303756ccc53c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 540930
  • 562502
  • 562501
  • UPC Code
  • 0307031985017
  • 0307031995016
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0703-1985Epoprostenol SodiumEpoprostenol Sodium
    0703-1995Epoprostenol SodiumEpoprostenol Sodium
    0173-0517FLOLANepoprostenol sodium
    0173-0519FLOLANepoprostenol sodium

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