NDC 54348-625

Sulfamethox-TMP DS

Sulfamethoxazole, Trimethoprim

Sulfamethox-TMP DS is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Sulfamethoxazole; Trimethoprim.

Product ID54348-625_8f75fb21-8080-76d4-e053-2995a90a59dd
NDC54348-625
Product TypeHuman Prescription Drug
Proprietary NameSulfamethox-TMP DS
Generic NameSulfamethoxazole, Trimethoprim
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-07-11
Marketing CategoryANDA / ANDA
Application NumberANDA076899
Labeler NamePharmPak, 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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-625-06

1 BOTTLE in 1 BOX (54348-625-06) > 6 TABLET in 1 BOTTLE
Marketing Start Date2019-07-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-625-06 [54348062506]

Sulfamethox-TMP DS TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-625-20 [54348062520]

Sulfamethox-TMP DS TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-625-14 [54348062514]

Sulfamethox-TMP DS TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

NDC 54348-625-10 [54348062510]

Sulfamethox-TMP DS TABLET
Marketing CategoryANDA
Application NumberANDA076899
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-11

Drug Details

Active Ingredients

IngredientStrength
SULFAMETHOXAZOLE800 mg/1

OpenFDA Data

SPL SET ID:ede74118-32c5-4f52-9823-509538e674c8
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]
    • 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]

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