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    NDC 25021-0215-98 fluorouracil 50 mg/mL Details

    fluorouracil 50 mg/mL

    fluorouracil is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is FLUOROURACIL.

    Product Information

    NDC 25021-0215
    Product ID 25021-215_2fcef624-1d6a-43ad-873b-495048cfc763
    Associated GPIs 21300030002030 21300030002035
    GCN Sequence Number 061671
    GCN Sequence Number Description fluorouracil VIAL 2.5 G/50ML INTRAVEN
    HIC3 V1B
    HIC3 Description ANTINEOPLASTIC - ANTIMETABOLITES
    GCN 97457
    HICL Sequence Number 003907
    HICL Sequence Number Description FLUOROURACIL
    Brand/Generic Generic
    Proprietary Name fluorouracil
    Proprietary Name Suffix n/a
    Non-Proprietary Name fluorouracil
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 50
    Active Ingredient Units mg/mL
    Substance Name FLUOROURACIL
    Labeler Name Sagent Pharmaceuticals
    Pharmaceutical Class Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA203609
    Listing Certified Through 2024-12-31

    Package

    NDC 25021-0215-98 (25021021598)

    NDC Package Code 25021-215-98
    Billing NDC 25021021598
    Package 1 BOTTLE in 1 CARTON (25021-215-98) / 50 mL in 1 BOTTLE
    Marketing Start Date 2016-09-15
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 37e35e8c-5d51-413b-a3a0-b72a18caaf65 Details

    Revised: 1/2017