NDC 0904-6553

Linezolid

Linezolid

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

Product ID0904-6553_72ce524e-80e1-4c10-bff3-dffb4d06c38a
NDC0904-6553
Product TypeHuman Prescription Drug
Proprietary NameLinezolid
Generic NameLinezolid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-21
Marketing CategoryANDA / ANDA
Application NumberANDA205517
Labeler NameMajor Pharmaceuticals
Substance NameLINEZOLID
Active Ingredient Strength600 mg/1
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6553-04

30 BLISTER PACK in 1 CARTON (0904-6553-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2015-12-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6553-04 [00904655304]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205517
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-21

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID600 mg/1

OpenFDA Data

SPL SET ID:bef116a8-427d-4855-86de-0017e01430b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311347
  • 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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