NDC 70069-361

Sulfamethoxazole and Trimethoprim

Sulfamethoxazole And Trimethoprim

Sulfamethoxazole and Trimethoprim is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Somerset Therapeutics, Llc. The primary component is Sulfamethoxazole; Trimethoprim.

Product ID70069-361_2ebefd0d-62d8-4a2e-b4de-b25b49b748af
NDC70069-361
Product TypeHuman Prescription Drug
Proprietary NameSulfamethoxazole and Trimethoprim
Generic NameSulfamethoxazole And Trimethoprim
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA212231
Labeler NameSomerset Therapeutics, LLC
Substance NameSULFAMETHOXAZOLE; TRIMETHOPRIM
Active Ingredient Strength80 mg/mL; mg/mL
Pharm ClassesSulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],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 Through2020-12-31

Packaging

NDC 70069-361-10

10 VIAL in 1 CARTON (70069-361-10) > 5 mL in 1 VIAL (70069-361-01)
Marketing Start Date2019-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70069-361-01 [70069036101]

Sulfamethoxazole and Trimethoprim INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA212231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-29

NDC 70069-361-10 [70069036110]

Sulfamethoxazole and Trimethoprim INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA212231
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-08-29

Drug Details

Active Ingredients

IngredientStrength
SULFAMETHOXAZOLE80 mg/mL

OpenFDA Data

SPL SET ID:ebb570bb-6e5e-489e-875c-9e7b3a6d716a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313137
  • 1809083
    • UPC Code
  • 0370069361016
  • 0370069363010
  • 0370069362013

    • Pharmacological Class

    • Sulfonamide Antimicrobial [EPC]
    • Sulfonamides [CS]
    • Cytochrome P450 2C9 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 "Sulfamethoxazole and Trimethoprim" or generic name "Sulfamethoxazole And Trimethoprim"

    NDCBrand NameGeneric Name
    0121-0853Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0121-4793Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0179-0138Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0179-0249Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0440-2406Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0527-5180Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0527-5181Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0615-0170Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0615-8121Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0703-9503Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0703-9514Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0703-9526Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    0904-2725Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    10544-053Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    10544-092Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    10544-525Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    10544-926Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    10544-940Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    12634-779SULFAMETHOXAZOLE and TRIMETHOPRIMSULFAMETHOXAZOLE and TRIMETHOPRIM
    17856-0496Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68071-3033Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68071-4489Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68071-4496Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68071-4710Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68071-4431Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68084-230Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68084-747Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68387-385Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68462-340Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68462-339Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68788-7122Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68788-8964Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68788-9086Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    68788-9500Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    69043-011Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    69043-010Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    70518-0066Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    70518-0863Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    70518-1517Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    70518-1400Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    70934-043Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    70934-049Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    71335-0762Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    75921-578Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    76413-151Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    76413-125Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    76413-135Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    17856-0823Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    21695-125Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
    21695-701Sulfamethoxazole and TrimethoprimSulfamethoxazole and Trimethoprim
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