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    NDC 63323-0165-05 Dexamethasone Sodium Phosphate 4 mg/mL Details

    Dexamethasone Sodium Phosphate 4 mg/mL

    Dexamethasone Sodium Phosphate is a INTRAMUSCULAR; INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is DEXAMETHASONE SODIUM PHOSPHATE.

    Product Information

    NDC 63323-0165
    Product ID 63323-165_db7f0736-ea5b-4b8c-92bb-a8353b033480
    Associated GPIs 22100020202005 22100020202040 22100020202045
    GCN Sequence Number 006778
    GCN Sequence Number Description dexamethasone sodium phosphate VIAL 4 MG/ML INJECTION
    HIC3 P5A
    HIC3 Description GLUCOCORTICOIDS
    GCN 27354
    HICL Sequence Number 002888
    HICL Sequence Number Description DEXAMETHASONE SODIUM PHOSPHATE
    Brand/Generic Generic
    Proprietary Name Dexamethasone Sodium Phosphate
    Proprietary Name Suffix n/a
    Non-Proprietary Name DEXAMETHASONE SODIUM PHOSPHATE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION, SOLUTION
    Route INTRAMUSCULAR; INTRAVENOUS
    Active Ingredient Strength 4
    Active Ingredient Units mg/mL
    Substance Name DEXAMETHASONE SODIUM PHOSPHATE
    Labeler Name Fresenius Kabi USA, LLC
    Pharmaceutical Class Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA084916
    Listing Certified Through 2024-12-31

    Package

    NDC 63323-0165-05 (63323016505)

    NDC Package Code 63323-165-05
    Billing NDC 63323016505
    Package 25 VIAL, MULTI-DOSE in 1 TRAY (63323-165-05) / 5 mL in 1 VIAL, MULTI-DOSE (63323-165-03)
    Marketing Start Date 2000-09-07
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 2b626a48-c7aa-4443-9164-a08ff069ccd1 Details

    Revised: 6/2018