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    NDC 70529-0048-01 Protherix 40 mg/mL Details

    Protherix 40 mg/mL

    Protherix is a INTRA-ARTICULAR; INTRAMUSCULAR INJECTION, SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by IT3 Medical LLC. The primary component is TRIAMCINOLONE ACETONIDE.

    Product Information

    NDC 70529-0048
    Product ID 70529-048_7e290c71-cfd5-4f73-bee9-576839b4af3c
    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 Protherix
    Proprietary Name Suffix n/a
    Non-Proprietary Name Triamcinolone Acetonide
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SUSPENSION
    Route INTRA-ARTICULAR; INTRAMUSCULAR
    Active Ingredient Strength 40
    Active Ingredient Units mg/mL
    Substance Name TRIAMCINOLONE ACETONIDE
    Labeler Name IT3 Medical LLC
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA207550
    Listing Certified Through 2023-12-31

    Package

    NDC 70529-0048-01 (70529004801)

    NDC Package Code 70529-048-01
    Billing NDC 70529004801
    Package 1 VIAL in 1 PACKAGE (70529-048-01) / 1 mL in 1 VIAL
    Marketing Start Date 2018-09-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL da9376f8-0133-46e4-af09-b84d43a829d1 Details

    Revised: 2/2022