NDC 63187-631

Polymyxin B Sulfate and Trimethoprim

Polymyxin B Sulfate And Trimethoprim Sulfate

Polymyxin B Sulfate and Trimethoprim is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Polymyxin B Sulfate; Trimethoprim Sulfate.

Product ID63187-631_1b694c4d-2049-4a40-ab48-19a15c8c8a44
NDC63187-631
Product TypeHuman Prescription Drug
Proprietary NamePolymyxin B Sulfate and Trimethoprim
Generic NamePolymyxin B Sulfate And Trimethoprim Sulfate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1997-02-14
Marketing CategoryANDA / ANDA
Application NumberANDA064120
Labeler NameProficient Rx LP
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 Through2022-12-31

Packaging

NDC 63187-631-10

1 BOTTLE, DROPPER in 1 CARTON (63187-631-10) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date2018-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63187-631-10 [63187063110]

Polymyxin B Sulfate and Trimethoprim SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA064120
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-01

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/mL

OpenFDA Data

SPL SET ID:d1f55327-156f-44cd-b0fc-b1a938e8aa73
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]
    • 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 Sulfate"

    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
    70518-0271Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    70518-1735Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim
    72189-005POLYMYXIN B SULFATE AND TRIMETHOPRIMPOLYMYXIN B SULFATE AND TRIMETHOPRIM
    61919-233POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
    0023-7824Polytrimpolymyxin b sulfate and trimethoprim sulfate
    50090-1540Polytrimpolymyxin b sulfate and trimethoprim sulfate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.