NDC 0781-3431

Linezolid

Linezolid

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

Product ID0781-3431_07968d8e-8929-4f8c-81d7-19a5cb0357ba
NDC0781-3431
Product TypeHuman Prescription Drug
Proprietary NameLinezolid
Generic NameLinezolid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-06-15
Marketing CategoryANDA / ANDA
Application NumberANDA200904
Labeler NameSandoz Inc
Substance NameLINEZOLID
Active Ingredient Strength200 mg/100mL
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-3431-46

100 mL in 1 BAG (0781-3431-46)
Marketing Start Date2016-06-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3431-46 [00781343146]

Linezolid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA200904
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-15

NDC 0781-3431-95 [00781343195]

Linezolid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA200904
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-15

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID200 mg/100mL

OpenFDA Data

SPL SET ID:a287cdf4-47a8-459f-8890-86181af5e836
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1662285
  • 1662278
  • UPC Code
  • 0307813431466
  • 0307813433460
  • 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

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