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    NDC 63323-0963-44 Acetylcysteine 200 mg/mL Details

    Acetylcysteine 200 mg/mL

    Acetylcysteine is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is ACETYLCYSTEINE.

    Product Information

    NDC 63323-0963
    Product ID 63323-963_c37a989c-c130-4837-ba1e-5789bfd5f3a4
    Associated GPIs 93000007002020
    GCN Sequence Number 024398
    GCN Sequence Number Description acetylcysteine VIAL 200 MG/ML INTRAVEN
    HIC3 C8E
    HIC3 Description ANTIDOTES,MISCELLANEOUS
    GCN 04391
    HICL Sequence Number 000189
    HICL Sequence Number Description ACETYLCYSTEINE
    Brand/Generic Generic
    Proprietary Name Acetylcysteine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Acetylcysteine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 200
    Active Ingredient Units mg/mL
    Substance Name ACETYLCYSTEINE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA200644
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0963-44 (63323096344)

    NDC Package Code 63323-963-44
    Billing NDC 63323096344
    Package 4 VIAL, SINGLE-DOSE in 1 CARTON (63323-963-44) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-963-41)
    Marketing Start Date 2012-11-09
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL d990ef51-ced2-4359-b99b-092334d2dc9b Details

    Revised: 10/2022