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    NDC 71406-0109-03 BUTALBITAL AND ACETAMINOPHEN 300; 50 mg/1; mg/1 Details

    BUTALBITAL AND ACETAMINOPHEN 300; 50 mg/1; mg/1

    BUTALBITAL AND ACETAMINOPHEN is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AACE Pharmaceuticals, Inc.. The primary component is ACETAMINOPHEN; BUTALBITAL.

    Product Information

    NDC 71406-0109
    Product ID 71406-109_ebf11b93-f92b-e6a6-e053-2995a90ac6de
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name BUTALBITAL AND ACETAMINOPHEN
    Proprietary Name Suffix n/a
    Non-Proprietary Name butalbital and acetaminophen
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 300; 50
    Active Ingredient Units mg/1; mg/1
    Substance Name ACETAMINOPHEN; BUTALBITAL
    Labeler Name AACE Pharmaceuticals, Inc.
    Pharmaceutical Class Barbiturate [EPC], Barbiturates [CS]
    DEA Schedule CIII
    Marketing Category ANDA
    Application Number ANDA214955
    Listing Certified Through 2023-12-31

    Package

    NDC 71406-0109-03 (71406010903)

    NDC Package Code 71406-109-03
    Billing NDC 71406010903
    Package 30 TABLET in 1 BOTTLE (71406-109-03)
    Marketing Start Date 2021-10-07
    NDC Exclude Flag N
    Pricing Information N/A