Search by Drug Name or NDC

    NDC 31722-0623-32 Roflumilast 500 ug/1 Details

    Roflumilast 500 ug/1

    Roflumilast is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Camber Pharmaceuticals, Inc.. The primary component is ROFLUMILAST.

    Product Information

    NDC 31722-0623
    Product ID 31722-623_fa61de4b-e3e1-e16c-e053-6394a90a6118
    Associated GPIs
    GCN Sequence Number 066612
    GCN Sequence Number Description roflumilast TABLET 500 MCG ORAL
    HIC3 Z2X
    HIC3 Description PHOSPHODIESTERASE-4 (PDE4) INHIBITORS
    GCN 28934
    HICL Sequence Number 037123
    HICL Sequence Number Description ROFLUMILAST
    Brand/Generic Generic
    Proprietary Name Roflumilast
    Proprietary Name Suffix n/a
    Non-Proprietary Name Roflumilast
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 500
    Active Ingredient Units ug/1
    Substance Name ROFLUMILAST
    Labeler Name Camber Pharmaceuticals, Inc.
    Pharmaceutical Class Phosphodiesterase 4 Inhibitor [EPC], Phosphodiesterase 4 Inhibitors [MoA]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA208213
    Listing Certified Through 2024-12-31

    Package

    NDC 31722-0623-32 (31722062332)

    NDC Package Code 31722-623-32
    Billing NDC 31722062332
    Package 100 BLISTER PACK in 1 CARTON (31722-623-32) / 10 TABLET in 1 BLISTER PACK (31722-623-31)
    Marketing Start Date 2022-10-15
    NDC Exclude Flag N
    Pricing Information N/A