NDC 52584-443

Levophed

Norepinephrine Bitartrate

Levophed is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc. The primary component is Norepinephrine Bitartrate.

Product ID52584-443_115b6ca6-5c5f-4ebd-82aa-3ef6c1c18f5c
NDC52584-443
Product TypeHuman Prescription Drug
Proprietary NameLevophed
Generic NameNorepinephrine Bitartrate
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2010-03-01
Marketing CategoryNDA / NDA
Application NumberNDA007513
Labeler NameGeneral Injectables & Vaccines, Inc
Substance NameNOREPINEPHRINE BITARTRATE
Active Ingredient Strength1 mg/mL
Pharm ClassesCatecholamine [EPC],Catecholamines [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-443-04

1 AMPULE in 1 BAG (52584-443-04) > 4 mL in 1 AMPULE
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-443-04 [52584044304]

Levophed INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA007513
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-01
Marketing End Date2019-05-01

Drug Details

Active Ingredients

IngredientStrength
NOREPINEPHRINE BITARTRATE1 mg/mL

OpenFDA Data

SPL SET ID:4d3531fb-82a4-41ab-8c36-eb0aace61f5c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 209217
  • 242969

    • Pharmacological Class

    • Catecholamine [EPC]
    • Catecholamines [CS]

    NDC Crossover Matching brand name "Levophed" or generic name "Norepinephrine Bitartrate"

    NDCBrand NameGeneric Name
    0409-1443LevophedNorepinephrine bitartrate
    0409-3375LEVOPHEDNOREPINEPHRINE BITARTRATE
    52584-443LevophedLevophed
    0143-9318Norepinephrine BitartrateNorepinephrine Bitartrate
    0338-0108NOREPINEPHRINE BITARTRATEnorepinephrine bitartrate
    0338-0112NOREPINEPHRINE BITARTRATEnorepinephrine bitartrate
    0703-1153Norepinephrine BitartrateNorepinephrine Bitartrate
    0781-3755NOREPINEPHRINE BITARTRATENorepinephrine Bitartrate
    25021-316Norepinephrine BitartrateNorepinephrine Bitartrate
    36000-162Norepinephrine bitartrateNorepinephrine bitartrate
    43066-997Norepinephrine Bitartratenorepinephrine bitartrate
    44567-640NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATE

    Trademark Results [Levophed]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LEVOPHED
    LEVOPHED
    77573754 3630361 Live/Registered
    Hospira, Inc.
    2008-09-18
    LEVOPHED
    LEVOPHED
    71520779 0434232 Dead/Expired
    WINTHROP CHEMICAL COMPANY, INC.
    1947-04-15
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