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    NDC 51316-0007-84 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1 Details

    Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60; 120 mg/1; mg/1

    Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy, Inc.. The primary component is FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.

    Product Information

    NDC 51316-0007
    Product ID 51316-007_46975e97-aa0a-4ae8-88e5-13d6fe3443de
    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 Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    Proprietary Name Suffix n/a
    Non-Proprietary Name Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
    Route ORAL
    Active Ingredient Strength 60; 120
    Active Ingredient Units mg/1; mg/1
    Substance Name FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
    Labeler Name CVS Pharmacy, Inc.
    Pharmaceutical Class Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA209116
    Listing Certified Through 2024-12-31

    Package

    NDC 51316-0007-84 (51316000784)

    NDC Package Code 51316-007-84
    Billing NDC 51316000784
    Package 3 BLISTER PACK in 1 CARTON (51316-007-84) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
    Marketing Start Date 2022-11-17
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e9161bb2-190f-14b3-e053-2995a90a9b2f Details

    Revised: 11/2022