NDC 39822-0171

Polymyxin B

Polymyxin B

Polymyxin B is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by X-gen Pharmaceuticals, Inc.. The primary component is Polymyxin B Sulfate.

Product ID39822-0171_b519442d-f8d6-4c0e-bf4a-824c77e398b4
NDC39822-0171
Product TypeHuman Prescription Drug
Proprietary NamePolymyxin B
Generic NamePolymyxin B
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2014-04-25
Marketing CategoryANDA / ANDA
Application NumberANDA202766
Labeler NameX-GEN Pharmaceuticals, Inc.
Substance NamePOLYMYXIN B SULFATE
Active Ingredient Strength500000 [USP'U]/1
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 39822-0171-7

10 VIAL in 1 CARTON (39822-0171-7) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0171-6)
Marketing Start Date2014-04-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 39822-0171-6 [39822017106]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-25
Marketing End Date2020-02-25

NDC 39822-0171-7 [39822017107]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-25
Marketing End Date2020-02-25
Inactivation Date2020-01-31
Reactivation Date2020-02-26

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE500000 [USP'U]/1

OpenFDA Data

SPL SET ID:805caef0-89df-4bcf-876d-9f6b7a89c9a3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204509
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Polymyxin B" or generic name "Polymyxin B"

    NDCBrand NameGeneric Name
    0143-9941Polymyxin BPolymyxin B sulfate
    39822-0166Polymyxin BPolymyxin B
    39822-0170Polymyxin BPolymyxin B
    39822-0171Polymyxin BPolymyxin B
    45932-0030POLYMYXIN BPOLYMYXIN B SULFATE
    47781-596Polymyxin Bpolymyxin B sulfate
    51991-939Polymyxin BPolymyxin B
    55150-234Polymyxin BPolymyxin B
    63323-321POLYMYXIN BPOLYMYXIN B SULFATE
    63323-367POLYMYXIN BPOLYMYXIN B SULFATE
    68083-174POLYMYXIN BPOLYMYXIN B SULFATE
    70594-049Polymyxin BPolymyxin B Sulfate
    70860-103Polymyxin Bpolymyxin B sulfate
    70860-124Polymyxin Bpolymyxin B sulfate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.