NDC 70594-049

Polymyxin B

Polymyxin B Sulfate

Polymyxin B is a Intramuscular; Intrathecal; Intravenous; Ophthalmic Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Xellia Pharmaceuticals Usa Llc. The primary component is Polymyxin B Sulfate.

Product ID70594-049_a4b361e1-e0b1-414c-b1d8-158f901c7163
NDC70594-049
Product TypeHuman Prescription Drug
Proprietary NamePolymyxin B
Generic NamePolymyxin B Sulfate
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Marketing Start Date2018-10-01
Marketing CategoryANDA / ANDA
Application NumberANDA202766
Labeler NameXellia Pharmaceuticals USA LLC
Substance NamePOLYMYXIN B SULFATE
Active Ingredient Strength500000 [USP'U]/1
Pharm ClassesPolymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 70594-049-01

1 VIAL, GLASS in 1 CARTON (70594-049-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70594-049-01 [70594004901]

Polymyxin B INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-01

NDC 70594-049-02 [70594004902]

Polymyxin B INJECTION, POWDER, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA202766
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE500000 [USP'U]/1

OpenFDA Data

SPL SET ID:b56f18c0-ef5e-4ed9-a5af-f79f3cd189b6
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

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