NDC 52584-054

Propofol

Propofol

Propofol is a Intravenous Injection, Emulsion in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Propofol.

Product ID52584-054_417d6f96-96eb-4d5c-9cb0-86eed3086f9d
NDC52584-054
Product TypeHuman Prescription Drug
Proprietary NamePropofol
Generic NamePropofol
Dosage FormInjection, Emulsion
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-04-11
Marketing CategoryANDA / ANDA
Application NumberANDA205307
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NamePROPOFOL
Active Ingredient Strength10 mg/mL
Pharm ClassesGeneral Anesthesia [PE],General Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52584-054-57

1 VIAL, SINGLE-DOSE in 1 BAG (52584-054-57) > 100 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-04-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-054-57 [52584005457]

Propofol INJECTION, EMULSION
Marketing CategoryANDA
Application NumberANDA205307
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-04-11
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
PROPOFOL10 mg/mL

OpenFDA Data

SPL SET ID:54cd5383-6841-4ded-b610-5cee1b35210f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1808217

    • Pharmacological Class

    • General Anesthesia [PE]
    • General Anesthetic [EPC]

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

    NDCBrand NameGeneric Name
    0069-0209PropofolPropofol
    0069-0234PropofolPropofol
    0069-0248PropofolPropofol
    0404-9943PROPOFOLpropofol
    0409-4699PROPOFOLPROPOFOL
    0409-6010PROPOFOLPROPOFOL
    0591-2136PropofolPropofol
    0641-6194PropofolPropofol
    0641-6195PropofolPropofol
    0641-6196PropofolPropofol
    16714-528propofolpropofol
    16714-690propofolpropofol
    16714-977propofolpropofol
    23155-345propofolpropofol
    25021-608propofolpropofol
    50090-4569PropofolPropofol
    51662-1293PROPOFOLPROPOFOL
    51662-1470PROPOFOLPROPOFOL
    51662-1471PROPOFOLPROPOFOL
    52584-054PropofolPropofol
    52584-098PROPOFOLpropofol
    52584-699PropofolPropofol
    18124-027Fresenius Propoven 2%PROPOFOL

    Trademark Results [Propofol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PROPOFOL
    PROPOFOL
    90235915 not registered Live/Pending
    Twilight Co.
    2020-10-05
    PROPOFOL
    PROPOFOL
    87725806 5534295 Live/Registered
    Liu Xiaojiao
    2017-12-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.