NDC 39822-0170

Polymyxin B

Polymyxin B

Polymyxin B is a Intramuscular; Intrathecal; Intravenous; Ophthalmic 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 ID39822-0170_5acacba1-5f1f-46ab-ba40-e13d90d5d7da
NDC39822-0170
Product TypeHuman Prescription Drug
Proprietary NamePolymyxin B
Generic NamePolymyxin B
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Marketing Start Date2014-01-15
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 39822-0170-2

10 VIAL in 1 CARTON (39822-0170-2) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0170-1)
Marketing Start Date2014-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 39822-0170-2 [39822017002]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-15
Marketing End Date2020-02-25
Inactivation Date2020-01-31
Reactivation Date2020-02-26

NDC 39822-0170-1 [39822017001]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-01-15
Marketing End Date2020-02-25

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE500000 [USP'U]/1

OpenFDA Data

SPL SET ID:caeee003-cfdc-4b57-a88b-5391ed7e73e5
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

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