NDC 0781-3425

Treprostinil

Treprostinil

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

Product ID0781-3425_19f50f18-7400-4b9f-b97a-49b16c48b207
NDC0781-3425
Product TypeHuman Prescription Drug
Proprietary NameTreprostinil
Generic NameTreprostinil
Dosage FormInjection
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2019-03-25
Marketing CategoryANDA / ANDA
Application NumberANDA203649
Labeler NameSandoz Inc
Substance NameTREPROSTINIL
Active Ingredient Strength50 mg/20mL
Pharm ClassesProstacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-3425-80

1 VIAL, MULTI-DOSE in 1 CARTON (0781-3425-80) > 20 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2019-03-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3425-80 [00781342580]

Treprostinil INJECTION
Marketing CategoryANDA
Application NumberANDA203649
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-25

Drug Details

Active Ingredients

IngredientStrength
TREPROSTINIL50 mg/20mL

OpenFDA Data

SPL SET ID:473297ca-a872-4052-a053-87dc8f0d3c13
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349408
  • 349409
  • 349410
  • 349407

    • Pharmacological Class

    • 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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