NDC 0517-0125

PROVAYBLUE

Methylene Blue

PROVAYBLUE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Methylene Blue.

Product ID0517-0125_5962f6c3-13e2-4597-abd6-4ff4ac8ed227
NDC0517-0125
Product TypeHuman Prescription Drug
Proprietary NamePROVAYBLUE
Generic NameMethylene Blue
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-04-08
Marketing CategoryNDA / NDA
Application NumberNDA204630
Labeler NameAmerican Regent, Inc.
Substance NameMETHYLENE BLUE
Active Ingredient Strength5 mg/mL
Pharm ClassesOxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0517-0125-05

5 AMPULE in 1 CARTON (0517-0125-05) > 2 mL in 1 AMPULE (0517-0125-01)
Marketing Start Date2020-04-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0125-01 [00517012501]

PROVAYBLUE INJECTION
Marketing CategoryNDA
Application NumberNDA204630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-18

NDC 0517-0125-05 [00517012505]

PROVAYBLUE INJECTION
Marketing CategoryNDA
Application NumberNDA204630
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-18

Drug Details

Active Ingredients

IngredientStrength
METHYLENE BLUE5 mg/mL

OpenFDA Data

SPL SET ID:4f6848e5-35ed-4046-b13c-3032b5ba3232
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2199324
  • 1788989
  • 2199323
  • 1788984
  • Pharmacological Class

    • Oxidation-Reduction Activity [MoA]
    • Oxidation-Reduction Agent [EPC]
    • Oxidation-Reduction Activity [MoA]
    • Oxidation-Reduction Agent [EPC]

    NDC Crossover Matching brand name "PROVAYBLUE" or generic name "Methylene Blue"

    NDCBrand NameGeneric Name
    0517-0125PROVAYBLUEmethylene blue
    0517-0371PROVAYBLUEmethylene blue
    0517-0374PROVAYBLUEmethylene blue
    0517-0381PROVAYBLUEmethylene blue
    82454-0125PROVAYBLUEmethylene blue
    82454-0371PROVAYBLUEmethylene blue
    82454-0374PROVAYBLUEmethylene blue
    82454-0381PROVAYBLUEmethylene blue
    17478-504Methylene BlueMethylene Blue
    52584-504Methylene BlueMethylene Blue
    54288-147Methylene BlueMethylene Blue

    Trademark Results [PROVAYBLUE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROVAYBLUE
    PROVAYBLUE
    86930634 5242388 Live/Registered
    PROVEPHARM LIFE SOLUTIONS
    2016-03-07

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