NDC 63323-393

Colistimethate

Colistimethate Sodium

Colistimethate is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Colistimethate Sodium.

Product ID63323-393_40ae8d43-e65a-4533-bb94-babdac91d4b8
NDC63323-393
Product TypeHuman Prescription Drug
Proprietary NameColistimethate
Generic NameColistimethate Sodium
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2009-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA065364
Labeler NameFresenius Kabi USA, LLC
Substance NameCOLISTIMETHATE SODIUM
Active Ingredient Strength150 mg/2mL
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-393-06

1 VIAL in 1 BOX (63323-393-06) > 2 mL in 1 VIAL
Marketing Start Date2009-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-393-06 [63323039306]

Colistimethate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065364
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2009-12-04

Drug Details

Active Ingredients

IngredientStrength
COLISTIMETHATE SODIUM150 mg/2mL

OpenFDA Data

SPL SET ID:ab241809-0d2f-44ba-829c-26be67ee623f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1117522
  • Pharmacological Class

    • Polymyxin-class Antibacterial [EPC]
    • Polymyxins [CS]

    Medicade Reported Pricing

    63323039306 COLISTIMETHATE 150 MG VIAL

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Colistimethate" or generic name "Colistimethate Sodium"

    NDCBrand NameGeneric Name
    25021-159Colistimethatecolistimethate sodium
    39822-0615ColistimethateColistimethate
    39822-0617Colistimethatecolistimethate sodium
    42023-131Colistimethatecolistimethate sodium
    45932-0023Colistimethatecolistimethate sodium
    63323-393ColistimethateCOLISTIMETHATE SODIUM
    70594-023ColistimethateColistimethate Sodium
    14789-201Colistimethate SodiumColistimethate Sodium
    23155-193COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUM
    42023-107Coly-Mycincolistimethate

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