NDC 71297-500

PrimSol

Trimethoprim Hydrochloride

PrimSol is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Allegis Holdings, Llc. The primary component is Trimethoprim Hydrochloride.

Product ID71297-500_9342b462-0983-4c9f-9b0e-e998b1061b31
NDC71297-500
Product TypeHuman Prescription Drug
Proprietary NamePrimSol
Generic NameTrimethoprim Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-05-04
Marketing CategoryNDA / NDA
Application NumberNDA074973
Labeler NameAllegis Holdings, LLC
Substance NameTRIMETHOPRIM HYDROCHLORIDE
Active Ingredient Strength50 mg/5mL
Pharm ClassesDihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71297-500-16

473 mL in 1 BOTTLE, PLASTIC (71297-500-16)
Marketing Start Date2017-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71297-500-20 [71297050020]

PrimSol SOLUTION
Marketing CategoryNDA
Application NumberNDA074973
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-04

NDC 71297-500-16 [71297050016]

PrimSol SOLUTION
Marketing CategoryNDA
Application NumberNDA074973
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-05-04

Drug Details

Active Ingredients

IngredientStrength
TRIMETHOPRIM HYDROCHLORIDE50 mg/5mL

OpenFDA Data

SPL SET ID:f40d6d72-31c3-4ef8-b86c-0230e06a9383
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 261353
  • 562707
  • Pharmacological Class

    • Dihydrofolate Reductase Inhibitor Antibacterial [EPC]
    • Dihydrofolate Reductase Inhibitors [MoA]
    • Cytochrome P450 2C8 Inhibitors [MoA]
    • Organic Cation Transporter 2 Inhibitors [MoA]
    • 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 "PrimSol" or generic name "Trimethoprim Hydrochloride"

    NDCBrand NameGeneric Name
    13551-501Primsoltrimethoprim hydrochloride
    71297-500PrimSolTRIMETHOPRIM HYDROCHLORIDE

    Trademark Results [PrimSol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PRIMSOL
    PRIMSOL
    77368235 3487990 Dead/Cancelled
    AYTU BIOSCIENCE, INC.
    2008-01-10
    PRIMSOL
    PRIMSOL
    74541334 1941818 Dead/Cancelled
    FSC LABORATORIES, INC.
    1994-06-23

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