NDC 53002-8621

Polymyxin B Sulfate and Trimethoprim

Polymyxin B Sulfate And Trimethoprim

Polymyxin B Sulfate and Trimethoprim is a Ophthalmic Solution in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Polymyxin B Sulfate; Trimethoprim Sulfate.

Product ID53002-8621_334a7d54-bb53-465e-a119-aa88b04d40a3
NDC53002-8621
Product TypeHuman Prescription Drug
Proprietary NamePolymyxin B Sulfate and Trimethoprim
Generic NamePolymyxin B Sulfate And Trimethoprim
Dosage FormSolution
Route of AdministrationOPHTHALMIC
Marketing Start Date1998-04-16
Marketing CategoryANDA / ANDA
Application NumberANDA064211
Labeler NameRPK Pharmaceuticals, Inc.
Substance NamePOLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
Active Ingredient Strength10000 [USP'U]/mL; mg/mL
Pharm ClassesPolymyxin-class Antibacterial [EPC],Polymyxins [CS],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-8621-1

10 mL in 1 BOTTLE, DROPPER (53002-8621-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-8621-1 [53002862101]

Polymyxin B Sulfate and Trimethoprim SOLUTION
Marketing CategoryANDA
Application NumberANDA064211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/mL

OpenFDA Data

SPL SET ID:76e1be2e-eb19-48d4-9bfb-88537de839ba
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 244967
  • Pharmacological Class

    • Polymyxin-class Antibacterial [EPC]
    • Polymyxins [CS]
    • Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
    • Dihydrofolate Reductase Inhibitors [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]

    NDC Crossover Matching brand name "Polymyxin B Sulfate and Trimethoprim" or generic name "Polymyxin B Sulfate And Trimethoprim"

    NDCBrand NameGeneric Name
    17478-703POLYMYXIN B SULFATE AND TRIMETHOPRIMpolymyxin b sulfate and trimethoprim
    21695-335Polymyxin B Sulfate and Trimethoprimpolymyxin B sulfate and trimethoprim
    24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    50090-2398Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    50090-2925Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    50436-4335Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    53002-8620Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    53002-8621Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    53217-244Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    53217-305Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    61314-628Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    61919-115POLYMYXIN B SULFATE AND TRIMETHOPRIMPOLYMYXIN B SULFATE AND TRIMETHOPRIM
    61919-215POLYMYXIN B SULFATE AND TRIMETHOPRIMPOLYMYXIN B SULFATE AND TRIMETHOPRIM
    63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    63187-834Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    68071-4103Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    68788-6927Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    68788-8152Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    70518-0271Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    72189-005POLYMYXIN B SULFATE AND TRIMETHOPRIMPOLYMYXIN B SULFATE AND TRIMETHOPRIM

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