NDC 47781-596

Polymyxin B

Polymyxin B Sulfate

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 Alvogen Inc.. The primary component is Polymyxin B Sulfate.

Product ID47781-596_7d37b4f2-f498-cadf-ba64-bd70c6d514e4
NDC47781-596
Product TypeHuman Prescription Drug
Proprietary NamePolymyxin B
Generic NamePolymyxin B Sulfate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; OPHTHALMIC
Marketing Start Date2017-09-23
Marketing CategoryANDA / ANDA
Application NumberANDA207322
Labeler NameAlvogen Inc.
Substance NamePOLYMYXIN B SULFATE
Active Ingredient Strength500000 [iU]/1
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 47781-596-91

10 VIAL in 1 CARTON (47781-596-91) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (47781-596-07)
Marketing Start Date2017-09-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-596-91 [47781059691]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207322
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-23

NDC 47781-596-07 [47781059607]

Polymyxin B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207322
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-09-23

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE500000 [iU]/1

OpenFDA Data

SPL SET ID:14b5d61f-746a-cba3-72ee-f4f3eb8558c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204509
  • UPC Code
  • 0347781596910
  • 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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