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    NDC 75834-0200-01 OFLOXACIN 300 mg/1 Details

    OFLOXACIN 300 mg/1

    OFLOXACIN is a ORAL TABLET, COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Nivagen Pharmaceuticals, Inc.. The primary component is OFLOXACIN.

    Product Information

    NDC 75834-0200
    Product ID 75834-200_991170ff-e65c-421f-b7f0-95f78e459844
    Associated GPIs 05000050000330
    GCN Sequence Number 015601
    GCN Sequence Number Description ofloxacin TABLET 300 MG ORAL
    HIC3 W1Q
    HIC3 Description QUINOLONE ANTIBIOTICS
    GCN 43692
    HICL Sequence Number 006035
    HICL Sequence Number Description OFLOXACIN
    Brand/Generic Generic
    Proprietary Name OFLOXACIN
    Proprietary Name Suffix n/a
    Non-Proprietary Name OFLOXACIN
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, COATED
    Route ORAL
    Active Ingredient Strength 300
    Active Ingredient Units mg/1
    Substance Name OFLOXACIN
    Labeler Name Nivagen Pharmaceuticals, Inc.
    Pharmaceutical Class Quinolone Antimicrobial [EPC], Quinolones [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA091656
    Listing Certified Through 2024-12-31

    Package

    NDC 75834-0200-01 (75834020001)

    NDC Package Code 75834-200-01
    Billing NDC 75834020001
    Package 100 TABLET, COATED in 1 BOTTLE (75834-200-01)
    Marketing Start Date 2019-01-25
    NDC Exclude Flag N
    Pricing Information N/A