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    NDC 59212-0700-12 Orapred 10 mg/1 Details

    Orapred 10 mg/1

    Orapred is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is PREDNISOLONE SODIUM PHOSPHATE.

    Product Information

    NDC 59212-0700
    Product ID 59212-700_e5eab968-b004-4c92-9a7b-e9f20b4b1134
    Associated GPIs 22100040207215
    GCN Sequence Number 060956
    GCN Sequence Number Description prednisolone sodium phosphate TAB RAPDIS 10 MG ORAL
    HIC3 P5A
    HIC3 Description GLUCOCORTICOIDS
    GCN 27108
    HICL Sequence Number 002871
    HICL Sequence Number Description PREDNISOLONE SODIUM PHOSPHATE
    Brand/Generic Brand
    Proprietary Name Orapred
    Proprietary Name Suffix ODT
    Non-Proprietary Name prednisolone sodium phosphate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form TABLET, ORALLY DISINTEGRATING
    Route ORAL
    Active Ingredient Strength 10
    Active Ingredient Units mg/1
    Substance Name PREDNISOLONE SODIUM PHOSPHATE
    Labeler Name Concordia Pharmaceuticals Inc.
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA021959
    Listing Certified Through 2024-12-31

    Package

    NDC 59212-0700-12 (59212070012)

    NDC Package Code 59212-700-12
    Billing NDC 59212070012
    Package 2 BLISTER PACK in 1 CARTON (59212-700-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (59212-700-06)
    Marketing Start Date 2020-06-30
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 1e379543-c4cf-4e72-953b-db15b7f0c2a1 Details

    Revised: 2/2022