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    NDC 10135-0718-12 Alendronate 35 mg/1 Details

    Alendronate 35 mg/1

    Alendronate is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Marlex Pharmaceuticals, Inc.. The primary component is ALENDRONATE SODIUM.

    Product Information

    NDC 10135-0718
    Product ID 10135-718_07eb9ff0-8b18-3d0b-e063-6294a90a40e3
    Associated GPIs 30042010100335
    GCN Sequence Number 047381
    GCN Sequence Number Description alendronate sodium TABLET 35 MG ORAL
    HIC3 P4L
    HIC3 Description BONE RESORPTION INHIBITORS
    GCN 12389
    HICL Sequence Number 010124
    HICL Sequence Number Description ALENDRONATE SODIUM
    Brand/Generic Generic
    Proprietary Name Alendronate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Alendronate sodium tablet
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 35
    Active Ingredient Units mg/1
    Substance Name ALENDRONATE SODIUM
    Labeler Name Marlex Pharmaceuticals, Inc.
    Pharmaceutical Class Bisphosphonate [EPC], Diphosphonates [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA090258
    Listing Certified Through 2024-12-31

    Package

    NDC 10135-0718-12 (10135071812)

    NDC Package Code 10135-718-12
    Billing NDC 10135071812
    Package 3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACK
    Marketing Start Date 2020-12-01
    NDC Exclude Flag N
    Pricing Information N/A