NDC 46708-183

Linezolid

Linezolid

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

Product ID46708-183_74f035ec-a0b1-4371-a17b-20b0b11864c9
NDC46708-183
Product TypeHuman Prescription Drug
Proprietary NameLinezolid
Generic NameLinezolid
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-22
Marketing CategoryANDA / ANDA
Application NumberANDA205233
Labeler NameAlembic Pharmaceuticals Limited
Substance NameLINEZOLID
Active Ingredient Strength600 mg/1
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 46708-183-20

20 TABLET, FILM COATED in 1 BOTTLE (46708-183-20)
Marketing Start Date2015-12-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-183-20 [46708018320]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205233
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-22

NDC 46708-183-31 [46708018331]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205233
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-22

NDC 46708-183-91 [46708018391]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205233
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-22

NDC 46708-183-30 [46708018330]

Linezolid TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA205233
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-22

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID600 mg/1

OpenFDA Data

SPL SET ID:74f035ec-a0b1-4371-a17b-20b0b11864c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311347
    • UPC Code
  • 0346708183318

    • 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.