NDC 39822-0617

Colistimethate

Colistimethate Sodium

Colistimethate is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by X-gen Pharmaceuticals, Inc.. The primary component is Colistimethate.

Product ID39822-0617_cb66e68f-efc4-4279-a780-8e363253b25e
NDC39822-0617
Product TypeHuman Prescription Drug
Proprietary NameColistimethate
Generic NameColistimethate Sodium
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2016-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA205356
Labeler NameX-GEN Pharmaceuticals, Inc.
Substance NameCOLISTIMETHATE
Active Ingredient Strength150 mg/2mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 39822-0617-1

1 VIAL in 1 CARTON (39822-0617-1) > 2 mL in 1 VIAL
Marketing Start Date2016-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 39822-0617-2 [39822061702]

Colistimethate INJECTION
Marketing CategoryANDA
Application NumberANDA205356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-01
Marketing End Date2020-02-24
Inactivation Date2020-01-31
Reactivation Date2020-02-25

NDC 39822-0617-1 [39822061701]

Colistimethate INJECTION
Marketing CategoryANDA
Application NumberANDA205356
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-01
Marketing End Date2020-02-24
Inactivation Date2020-01-31
Reactivation Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
COLISTIMETHATE150 mg/2mL

OpenFDA Data

SPL SET ID:318b3c36-89f8-4423-984e-361cf0d51c8b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1117522
  • 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
    23155-193COLISTIMETHATE SODIUMCOLISTIMETHATE SODIUM
    42023-107Coly-Mycincolistimethate

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