NDC 0173-0519

FLOLAN

Epoprostenol Sodium

FLOLAN is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Glaxosmithkline Llc. The primary component is Epoprostenol Sodium.

Product ID0173-0519_0cf298ad-7945-4bd1-9ee9-b988f4452a6e
NDC0173-0519
Product TypeHuman Prescription Drug
Proprietary NameFLOLAN
Generic NameEpoprostenol Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1995-12-08
Marketing CategoryNDA / NDA
Application NumberNDA020444
Labeler NameGlaxoSmithKline LLC
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 0173-0519-00

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0173-0519-00)
Marketing Start Date1995-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0173-0519-00 [00173051900]

FLOLAN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA020444
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-12-08

Drug Details

Active Ingredients

IngredientStrength
EPOPROSTENOL SODIUM1.5 mg/1

OpenFDA Data

SPL SET ID:8e4b636e-ee9c-4111-779d-28c8369d283b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 211200
  • 562501
  • 562502
  • 211199
  • Pharmacological Class

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

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

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

    Trademark Results [FLOLAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FLOLAN
    FLOLAN
    74658215 not registered Dead/Abandoned
    Burroughs Wellcome Co.
    1995-04-10
    FLOLAN
    FLOLAN
    74658212 not registered Dead/Abandoned
    Burroughs Wellcome Co.
    1995-04-10
    FLOLAN
    FLOLAN
    74658211 not registered Dead/Abandoned
    Burroughs Wellcome Co.
    1995-04-10
    FLOLAN
    FLOLAN
    73363030 1251465 Live/Registered
    Burroughs Wellcome Co.
    1982-05-05

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