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    NDC 00143-9297-01 Dantrolene 20 mg/1 Details

    Dantrolene 20 mg/1

    Dantrolene is a INTRAVENOUS INJECTION, POWDER, FOR SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is DANTROLENE SODIUM.

    Product Information

    NDC 00143-9297
    Product ID 0143-9297_eafbaffa-64c7-4bee-9ad5-235399687f81
    Associated GPIs 75200010102105
    GCN Sequence Number 004669
    GCN Sequence Number Description dantrolene sodium VIAL 20 MG INTRAVEN
    HIC3 H6H
    HIC3 Description SKELETAL MUSCLE RELAXANTS
    GCN 17950
    HICL Sequence Number 001947
    HICL Sequence Number Description DANTROLENE SODIUM
    Brand/Generic Generic
    Proprietary Name Dantrolene
    Proprietary Name Suffix n/a
    Non-Proprietary Name Dantrolene
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, POWDER, FOR SOLUTION
    Route INTRAVENOUS
    Active Ingredient Strength 20
    Active Ingredient Units mg/1
    Substance Name DANTROLENE SODIUM
    Labeler Name Hikma Pharmaceuticals USA Inc.
    Pharmaceutical Class Decreased Striated Muscle Contraction [PE], Decreased Striated Muscle Tone [PE], Skeletal Muscle Relaxant [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA204762
    Listing Certified Through 2024-12-31

    Package

    NDC 00143-9297-01 (00143929701)

    NDC Package Code 0143-9297-01
    Billing NDC 00143929701
    Package 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9297-01)
    Marketing Start Date 2017-06-19
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL ab0efc75-0598-4f4e-91ad-6195bb2661fe Details

    Revised: 2/2022