NDC 52959-609

POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE

Polymyxin B Sulfate, Trimethoprim Sulfate

POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by H.j. Harkins Company, Inc.. The primary component is Polymyxin B Sulfate; Trimethoprim Sulfate.

Product ID52959-609_998080ce-a00c-4518-92fd-a985679ad681
NDC52959-609
Product TypeHuman Prescription Drug
Proprietary NamePOLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE
Generic NamePolymyxin B Sulfate, Trimethoprim Sulfate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date1997-04-29
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA050567
Labeler NameH.J. Harkins Company, 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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 52959-609-10

1 BOTTLE, DROPPER in 1 CARTON (52959-609-10) > 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date1997-04-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52959-609-10 [52959060910]

POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATE SOLUTION/ DROPS
Marketing CategoryNDA authorized generic
Application NumberNDA050567
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1997-04-29
Inactivation Date2019-11-13

Drug Details

Active Ingredients

IngredientStrength
POLYMYXIN B SULFATE10000 [USP'U]/mL

OpenFDA Data

SPL SET ID:0461401a-17c1-460f-b9ec-ff1cfe514f57
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 SULFATE" or generic name "Polymyxin B Sulfate, Trimethoprim Sulfate"

    NDCBrand NameGeneric Name
    50090-2064POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfate
    52959-609POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfate
    55700-105POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfate
    60758-908POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfate
    61919-233POLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATEPOLYMYXIN B SULFATE AND TRIMETHOPRIM SULFATE
    70518-3206POLYMYXIN B SULFATE and TRIMETHOPRIM SULFATEpolymyxin B sulfate, trimethoprim sulfate
    24208-315Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    50090-2398Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    50436-4335Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    53002-8620Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    53217-244Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    63187-631Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    68071-1651Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    68788-8152Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    70518-0271Polymyxin B Sulfate and TrimethoprimPolymyxin B Sulfate and Trimethoprim Sulfate
    0023-7824Polytrimpolymyxin b sulfate and trimethoprim sulfate
    50090-1540Polytrimpolymyxin b sulfate and trimethoprim sulfate
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