NDC 68382-413

Linezolid

Linezolid

Linezolid is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Linezolid.

Product ID68382-413_390ed8d7-a2cf-4470-8b00-40575ffbf6f2
NDC68382-413
Product TypeHuman Prescription Drug
Proprietary NameLinezolid
Generic NameLinezolid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-08-09
Marketing CategoryANDA / ANDA
Application NumberANDA206097
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameLINEZOLID
Active Ingredient Strength600 mg/1
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68382-413-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-413-01)
Marketing Start Date2017-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-413-01 [68382041301]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09

NDC 68382-413-16 [68382041316]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09

NDC 68382-413-05 [68382041305]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09

NDC 68382-413-92 [68382041392]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09

NDC 68382-413-06 [68382041306]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09

NDC 68382-413-10 [68382041310]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206097
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-09

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID600 mg/1

OpenFDA Data

SPL SET ID:6d0c59d0-ca09-466b-aee7-d7ecac0588e9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311347
    • UPC Code
  • 0368382413017

    • 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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