NDC 45932-0030

POLYMYXIN B

Polymyxin B Sulfate

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

Product ID45932-0030_5039c2fa-cc43-4787-933c-a9943ca381eb
NDC45932-0030
Product TypeHuman Prescription Drug
Proprietary NamePOLYMYXIN B
Generic NamePolymyxin B Sulfate
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Marketing Start Date2014-01-24
Marketing CategoryANDA / ANDA
Application NumberANDA202766
Labeler NameXellia Pharmaceuticals ApS
Substance NamePOLYMYXIN B SULFATE
Active Ingredient Strength500000 1/1
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 45932-0030-1

10 VIAL in 1 CARTON (45932-0030-1) > 1 INJECTION in 1 VIAL
Marketing Start Date2014-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45932-0030-1 [45932003001]

POLYMYXIN B INJECTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-24
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE500000 1/1

OpenFDA Data

SPL SET ID:132fe072-9c9a-4c56-9004-c27ee6a467ae
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 Sulfate"

    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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