NDC 0187-4302

Nitropress

Sodium Nitroprusside

Nitropress is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Sodium Nitroprusside.

Product ID0187-4302_477e3345-75a9-4c1b-aecd-99fc2b943d61
NDC0187-4302
Product TypeHuman Prescription Drug
Proprietary NameNitropress
Generic NameSodium Nitroprusside
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA071961
Labeler NameBausch Health US, LLC
Substance NameSODIUM NITROPRUSSIDE
Active Ingredient Strength50 mg/2mL
Pharm ClassesVasodilation [PE],Vasodilator [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0187-4302-02

1 VIAL in 1 CARTON (0187-4302-02) > 2 mL in 1 VIAL
Marketing Start Date2013-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-4302-02 [00187430202]

Nitropress INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA071961
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-12-01

Drug Details

Active Ingredients

IngredientStrength
SODIUM NITROPRUSSIDE50 mg/2mL

OpenFDA Data

SPL SET ID:123c61ec-d930-499e-a27a-0cd82d2bd8ce
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 207678
  • 240793
  • Pharmacological Class

    • Vasodilation [PE]
    • Vasodilator [EPC]

    NDC Crossover Matching brand name "Nitropress" or generic name "Sodium Nitroprusside"

    NDCBrand NameGeneric Name
    0187-4302Nitropresssodium nitroprusside
    51754-1006NIPRIDE RTUSodium Nitroprusside
    51754-1018NIPRIDE RTUSodium Nitroprusside
    51754-1029NIPRIDE RTUSodium Nitroprusside
    0548-9401Sodium NitroprussideSodium Nitroprusside
    14335-132Sodium NitroprussideSodium Nitroprusside
    14335-133Sodium NitroprussideSodium Nitroprusside
    14335-134Sodium NitroprussideSodium Nitroprusside
    14789-012sodium nitroprussidesodium nitroprusside
    17478-014Sodium NitroprussideSodium Nitroprusside
    25021-310Sodium NitroprussideSodium Nitroprusside
    25208-003SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE
    42571-265SODIUM NITROPRUSSIDEsodium nitroprusside
    43598-587Sodium NitroprussideSodium Nitroprusside
    55150-320SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE
    65145-101Sodium NitroprussideSodium Nitroprusside
    67457-839Sodium nitroprussideSodium nitroprusside
    67457-999Sodium nitroprussideSodium nitroprusside
    69097-532SODIUM NITROPRUSSIDESODIUM NITROPRUSSIDE
    70069-261Sodium NitroprussideSodium Nitroprusside
    70121-1189Sodium nitroprussideSodium nitroprusside
    70436-028sodium nitroprussidesodium nitroprusside
    70655-014Sodium NitroprussideSodium Nitroprusside
    71288-202Sodium NitroprussideSodium Nitroprusside

    Trademark Results [Nitropress]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NITROPRESS
    NITROPRESS
    73325506 1217270 Live/Registered
    Abbott Laboratories
    1981-08-27

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.