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    NDC 71335-0194-06 Butalbital, Acetaminophen, Caffeine and Codeine Phosphate 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1 Details

    Butalbital, Acetaminophen, Caffeine and Codeine Phosphate 325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1

    Butalbital, Acetaminophen, Caffeine and Codeine Phosphate is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE.

    Product Information

    NDC 71335-0194
    Product ID 71335-0194_05725e50-34b6-49d4-8022-cb204fcf8978
    Associated GPIs 65991004100115
    GCN Sequence Number 004149
    GCN Sequence Number Description butalbit/acetamin/caff/codeine CAPSULE 50-325-30 ORAL
    HIC3 H3M
    HIC3 Description OPIOID,NON-SALICYL.ANALGESIC,BARBITURATE,XANTHINE
    GCN 70140
    HICL Sequence Number 001713
    HICL Sequence Number Description BUTALBITAL/ACETAMINOPHEN/CAFFEINE/CODEINE PHOSPHATE
    Brand/Generic Generic
    Proprietary Name Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 325; 50; 40; 30
    Active Ingredient Units mg/1; mg/1; mg/1; mg/1
    Substance Name ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
    Labeler Name Bryant Ranch Prepack
    Pharmaceutical Class Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]
    DEA Schedule CIII
    Marketing Category ANDA
    Application Number ANDA076560
    Listing Certified Through 2024-12-31

    Package

    NDC 71335-0194-06 (71335019406)

    NDC Package Code 71335-0194-6
    Billing NDC 71335019406
    Package 15 CAPSULE in 1 BOTTLE (71335-0194-6)
    Marketing Start Date 2021-12-27
    NDC Exclude Flag N
    Pricing Information N/A