NDC 57664-683

Linezolid

Linezolid

Linezolid is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Linezolid.

Product ID57664-683_063ea975-bced-4544-afb2-0de2d7f62b5f
NDC57664-683
Product TypeHuman Prescription Drug
Proprietary NameLinezolid
Generic NameLinezolid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-02-01
Marketing CategoryANDA / ANDA
Application NumberANDA207354
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameLINEZOLID
Active Ingredient Strength600 mg/300mL
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 57664-683-57

10 BAG in 1 BOX (57664-683-57) > 300 mL in 1 BAG (57664-683-31)
Marketing Start Date2017-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57664-683-31 [57664068331]

Linezolid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207354
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-02-01

NDC 57664-683-57 [57664068357]

Linezolid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA207354
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-02-01

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID600 mg/300mL

OpenFDA Data

SPL SET ID:870c9600-04d5-4b44-a5b5-02252a310f22
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1662285
  • 1662278
  • UPC Code
  • 0357664683316
  • 0357664682302
  • Pharmacological Class

    • Oxazolidinone Antibacterial [EPC]
    • Oxazolidinones [CS]

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

    NDCBrand NameGeneric Name
    67877-419LinezolidLinezolid
    0054-0319LinezolidLinezolid
    0409-4883LinezolidLinezolid
    68382-413LinezolidLinezolid
    68462-291LinezolidLinezolid
    70518-0527LinezolidLinezolid
    70771-1111LinezolidLinezolid
    0781-3433LinezolidLinezolid
    0781-3431LinezolidLinezolid
    0904-6553LinezolidLinezolid
    0093-7490LinezolidLinezolid
    0093-8244LINEZOLIDLINEZOLID
    25021-169linezolidlinezolid
    31722-749LinezolidLinezolid
    40032-022LinezolidLinezolid
    42292-008LinezolidLinezolid
    46708-183LinezolidLinezolid
    50268-471LinezolidLinezolid
    55150-242LinezolidLinezolid
    57664-682LinezolidLinezolid
    57664-683LinezolidLinezolid
    59762-1308LinezolidLinezolid
    59762-1307LinezolidLinezolid
    60505-4362LINEZOLIDLINEZOLID
    60687-309LinezolidLinezolid
    60687-189LinezolidLinezolid
    62332-183LinezolidLinezolid
    63323-713LinezolidLinezolid
    0378-7077LinezolidLinezolid
    65162-777LinezolidLinezolid
    66298-7131LinezolidLinezolid
    67457-324linezolidlinezolid
    67457-843linezolidlinezolid
    32228-003linezolidlinezolid
    72606-001linezolidlinezolid
    0009-4992Zyvoxlinezolid
    0009-5136Zyvoxlinezolid
    0009-5137Zyvoxlinezolid
    0009-5138Zyvoxlinezolid
    0009-5140Zyvoxlinezolid

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