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    NDC 23594-0375-01 Cefaclor 375 mg/5mL Details

    Cefaclor 375 mg/5mL

    Cefaclor is a ORAL FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aytu Therapeutics, LLC. The primary component is CEFACLOR.

    Product Information

    NDC 23594-0375
    Product ID 23594-375_bf7dced3-822e-df9b-e053-2995a90ae2e7
    Associated GPIs 02200040001915
    GCN Sequence Number 009109
    GCN Sequence Number Description cefaclor SUSP RECON 375 MG/5ML ORAL
    HIC3 W1X
    HIC3 Description CEPHALOSPORIN ANTIBIOTICS - 2ND GENERATION
    GCN 40033
    HICL Sequence Number 003983
    HICL Sequence Number Description CEFACLOR
    Brand/Generic Generic
    Proprietary Name Cefaclor
    Proprietary Name Suffix n/a
    Non-Proprietary Name cefaclor
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form FOR SUSPENSION
    Route ORAL
    Active Ingredient Strength 375
    Active Ingredient Units mg/5mL
    Substance Name CEFACLOR
    Labeler Name Aytu Therapeutics, LLC
    Pharmaceutical Class Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA065412
    Listing Certified Through 2022-12-31

    Package

    NDC 23594-0375-01 (23594037501)

    NDC Package Code 23594-375-01
    Billing NDC 23594037501
    Package 100 mL in 1 BOTTLE, PLASTIC (23594-375-01)
    Marketing Start Date 2015-10-26
    NDC Exclude Flag N
    Pricing Information N/A