NDC 42023-207

Treprostinil

Treprostinil

Treprostinil is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Treprostinil.

Product ID42023-207_1798515a-9b6d-4718-b259-8f893c14b904
NDC42023-207
Product TypeHuman Prescription Drug
Proprietary NameTreprostinil
Generic NameTreprostinil
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2019-09-25
Marketing CategoryANDA / ANDA
Application NumberANDA209382
Labeler NamePar Pharmaceutical, Inc.
Substance NameTREPROSTINIL
Active Ingredient Strength3 mg/mL
Pharm ClassesProstacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 42023-207-01

1 VIAL in 1 CARTON (42023-207-01) > 20 mL in 1 VIAL
Marketing Start Date2019-09-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42023-207-01 [42023020701]

Treprostinil INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA209382
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-09-25

Drug Details

Active Ingredients

IngredientStrength
TREPROSTINIL2.5 mg/mL

OpenFDA Data

SPL SET ID:f251795d-aba6-4762-bdd9-477daab6e9a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349408
  • 349409
  • 349410
  • 349407
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Treprostinil" or generic name "Treprostinil"

    NDCBrand NameGeneric Name
    0703-0666TreprostinilTreprostinil
    0703-0676TreprostinilTreprostinil
    0703-0686TreprostinilTreprostinil
    0703-0696TreprostinilTreprostinil
    0781-3420Treprostiniltreprostinil
    0781-3425Treprostiniltreprostinil
    0781-3427Treprostiniltreprostinil
    0781-3430Treprostiniltreprostinil
    42023-206TreprostinilTreprostinil
    42023-207TreprostinilTreprostinil
    42023-208TreprostinilTreprostinil
    42023-209TreprostinilTreprostinil
    62332-514TreprostinilTreprostinil
    62332-515TreprostinilTreprostinil
    62332-516TreprostinilTreprostinil
    62332-517TreprostinilTreprostinil
    66302-101Remodulintreprostinil
    66302-102Remodulintreprostinil

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