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    NDC 68180-0197-09 Telmisartan and Amlodipine 10; 40 mg/1; mg/1 Details

    Telmisartan and Amlodipine 10; 40 mg/1; mg/1

    Telmisartan and Amlodipine is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is AMLODIPINE BESYLATE; TELMISARTAN.

    Product Information

    NDC 68180-0197
    Product ID 68180-197_17a6182b-5050-470e-aa1d-1605fa9e088e
    Associated GPIs 36993002700330
    GCN Sequence Number 065747
    GCN Sequence Number Description telmisartan/amlodipine TABLET 40 MG-10MG ORAL
    HIC3 A4H
    HIC3 Description ANGIOTENSIN RECEPTOR BLOCKR-CALCIUM CHANNEL BLOCKR
    GCN 27784
    HICL Sequence Number 036697
    HICL Sequence Number Description TELMISARTAN/AMLODIPINE BESYLATE
    Brand/Generic Generic
    Proprietary Name Telmisartan and Amlodipine
    Proprietary Name Suffix n/a
    Non-Proprietary Name Telmisartan and Amlodipine
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET
    Route ORAL
    Active Ingredient Strength 10; 40
    Active Ingredient Units mg/1; mg/1
    Substance Name AMLODIPINE BESYLATE; TELMISARTAN
    Labeler Name Lupin Pharmaceuticals, Inc.
    Pharmaceutical Class Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA201586
    Listing Certified Through 2024-12-31

    Package

    NDC 68180-0197-09 (68180019709)

    NDC Package Code 68180-197-09
    Billing NDC 68180019709
    Package 90 TABLET in 1 BOTTLE (68180-197-09)
    Marketing Start Date 2014-01-08
    NDC Exclude Flag N
    Pricing Information N/A