Search by Drug Name or NDC

    NDC 67457-0778-05 Sulfamethoxazole and Trimethoprim 80; 16 mg/mL; mg/mL Details

    Sulfamethoxazole and Trimethoprim 80; 16 mg/mL; mg/mL

    Sulfamethoxazole and Trimethoprim is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is SULFAMETHOXAZOLE; TRIMETHOPRIM.

    Product Information

    NDC 67457-0778
    Product ID 67457-778_aa80137a-281f-41cd-b8df-0f08df701854
    Associated GPIs 16990002302010
    GCN Sequence Number 009393
    GCN Sequence Number Description sulfamethoxazole/trimethoprim VIAL 80-16MG/ML INTRAVEN
    HIC3 W2A
    HIC3 Description ABSORBABLE SULFONAMIDE ANTIBACTERIAL AGENTS
    GCN 90139
    HICL Sequence Number 004071
    HICL Sequence Number Description SULFAMETHOXAZOLE/TRIMETHOPRIM
    Brand/Generic Generic
    Proprietary Name Sulfamethoxazole and Trimethoprim
    Proprietary Name Suffix n/a
    Non-Proprietary Name sulfamethoxazole and trimethoprim
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAVENOUS
    Active Ingredient Strength 80; 16
    Active Ingredient Units mg/mL; mg/mL
    Substance Name SULFAMETHOXAZOLE; TRIMETHOPRIM
    Labeler Name Mylan Institutional LLC
    Pharmaceutical Class Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Su
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA206607
    Listing Certified Through 2024-12-31

    Package

    NDC 67457-0778-05 (67457077805)

    NDC Package Code 67457-778-05
    Billing NDC 67457077805
    Package 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-778-05) / 5 mL in 1 VIAL, SINGLE-DOSE (67457-778-00)
    Marketing Start Date 2017-12-31
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 793c75eb-dd65-4b6d-ac46-6e57ce1334f7 Details

    Revised: 6/2021