NDC 45932-0023

Colistimethate

Colistimethate Sodium

Colistimethate is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Xellia Pharmaceuticals Aps. The primary component is Colistimethate.

Product ID45932-0023_55c6e7db-dff7-4a3b-9cb1-78255cae8b09
NDC45932-0023
Product TypeHuman Prescription Drug
Proprietary NameColistimethate
Generic NameColistimethate Sodium
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2012-11-22
Marketing CategoryANDA / ANDA
Application NumberANDA205356
Labeler NameXellia Pharmaceuticals ApS
Substance NameCOLISTIMETHATE
Active Ingredient Strength150 mg/2mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45932-0023-1

1 VIAL in 1 CARTON (45932-0023-1) > 2 mL in 1 VIAL
Marketing Start Date2012-11-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45932-0023-4 [45932002304]

Colistimethate INJECTION
Marketing CategoryANDA
Application NumberANDA205356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-22

NDC 45932-0023-1 [45932002301]

Colistimethate INJECTION
Marketing CategoryANDA
Application NumberANDA205356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-22

NDC 45932-0023-2 [45932002302]

Colistimethate INJECTION
Marketing CategoryANDA
Application NumberANDA205356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-22

NDC 45932-0023-3 [45932002303]

Colistimethate INJECTION
Marketing CategoryANDA
Application NumberANDA205356
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-11-22

Drug Details

Active Ingredients

IngredientStrength
COLISTIMETHATE150 mg/2mL

OpenFDA Data

SPL SET ID:94bd9798-5d36-48d0-924b-319662c97e8c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1117522
    • UPC Code
  • 0045932002340

    • 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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