NDC 68387-385

Sulfamethoxazole and Trimethoprim

Sulfamethoxazole And Trimethoprim

Sulfamethoxazole and Trimethoprim is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Keltman Pharmaceuticals Inc.. The primary component is Sulfamethoxazole; Trimethoprim.

Product ID68387-385_43ff2749-e5bb-4baf-8d73-7c56b7cd2eb4
NDC68387-385
Product TypeHuman Prescription Drug
Proprietary NameSulfamethoxazole and Trimethoprim
Generic NameSulfamethoxazole And Trimethoprim
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA076899
Labeler NameKeltman Pharmaceuticals Inc.
Substance NameSULFAMETHOXAZOLE; TRIMETHOPRIM
Active Ingredient Strength800 mg/1; mg/1
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68387-385-10

10 TABLET in 1 BOTTLE, PLASTIC (68387-385-10)
Marketing Start Date2010-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68387-385-30 [68387038530]

Sulfamethoxazole and Trimethoprim TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-01
Inactivation Date2019-10-29

NDC 68387-385-10 [68387038510]

Sulfamethoxazole and Trimethoprim TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-01
Inactivation Date2019-10-29

NDC 68387-385-20 [68387038520]

Sulfamethoxazole and Trimethoprim TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-03-01
Inactivation Date2019-10-29

NDC 68387-385-14 [68387038514]

Sulfamethoxazole and Trimethoprim TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-03-01
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
SULFAMETHOXAZOLE800 mg/1

OpenFDA Data

SPL SET ID:b1645c68-9dfc-4079-8bf0-e61e9b2e4ed0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198335

    • 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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