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    NDC 00517-1791-01 Hydroxyprogesterone Caproate 250 mg/mL Details

    Hydroxyprogesterone Caproate 250 mg/mL

    Hydroxyprogesterone Caproate is a INTRAMUSCULAR INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is HYDROXYPROGESTERONE CAPROATE.

    Product Information

    NDC 00517-1791
    Product ID 0517-1791_abe2312b-bc06-497b-835e-b9526fbe09bf
    Associated GPIs 26000010101710
    GCN Sequence Number 075680
    GCN Sequence Number Description hydroxyprogesterone caproat/PF VIAL 250 MG/ML INTRAMUSC
    HIC3 P0G
    HIC3 Description PREGNANCY MAINTAINING AGENT,HORMONAL
    GCN 40784
    HICL Sequence Number 043985
    HICL Sequence Number Description HYDROXYPROGESTERONE CAPROATE/PF
    Brand/Generic Generic
    Proprietary Name Hydroxyprogesterone Caproate
    Proprietary Name Suffix n/a
    Non-Proprietary Name Hydroxyprogesterone Caproate
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form INJECTION
    Route INTRAMUSCULAR
    Active Ingredient Strength 250
    Active Ingredient Units mg/mL
    Substance Name HYDROXYPROGESTERONE CAPROATE
    Labeler Name American Regent, Inc.
    Pharmaceutical Class Progesterone Congeners [CS], Progestin [EPC]
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210723
    Listing Certified Through 2024-12-31

    Package

    NDC 00517-1791-01 (00517179101)

    NDC Package Code 0517-1791-01
    Billing NDC 00517179101
    Package 1 VIAL in 1 BOX (0517-1791-01) / 1 mL in 1 VIAL
    Marketing Start Date 2019-03-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL e75abf24-efa6-4008-a576-80ed92968197 Details

    Revised: 1/2019