NDC 72606-001

linezolid

Linezolid

linezolid is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Celltrion Usa, Inc.. The primary component is Linezolid.

Product ID72606-001_2911b0d6-2965-4cd8-861d-983321b17411
NDC72606-001
Product TypeHuman Prescription Drug
Proprietary Namelinezolid
Generic NameLinezolid
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-04-25
Marketing CategoryANDA / ANDA
Application NumberANDA210702
Labeler NameCELLTRION USA, INC.
Substance NameLINEZOLID
Active Ingredient Strength600 mg/1
Pharm ClassesOxazolidinone Antibacterial [EPC],Oxazolidinones [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 72606-001-03

3 BLISTER PACK in 1 CARTON (72606-001-03) > 10 TABLET in 1 BLISTER PACK
Marketing Start Date2020-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72606-001-11 [72606000111]

linezolid TABLET
Marketing CategoryANDA
Application NumberANDA210702
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-02
Marketing End Date2019-10-04

NDC 72606-001-07 [72606000107]

linezolid TABLET
Marketing CategoryANDA
Application NumberANDA210702
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-02

NDC 72606-001-03 [72606000103]

linezolid TABLET
Marketing CategoryANDA
Application NumberANDA210702
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-22

NDC 72606-001-08 [72606000108]

linezolid TABLET
Marketing CategoryANDA
Application NumberANDA210702
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-22

Drug Details

Active Ingredients

IngredientStrength
LINEZOLID600 mg/1

OpenFDA Data

SPL SET ID:02192109-08e9-428a-bc5e-c606c2870b0d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 311347
  • UPC Code
  • 0372606001119
  • 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.