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    NDC 00299-3822-02 ORACEA 40 mg/1 Details

    ORACEA 40 mg/1

    ORACEA is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Galderma Laboratories, L.P.. The primary component is DOXYCYCLINE.

    Product Information

    NDC 00299-3822
    Product ID 0299-3822_a78ea97d-fa82-40b7-aa5c-0536b364cc69
    Associated GPIs 90060025006520
    GCN Sequence Number 060942
    GCN Sequence Number Description doxycycline monohydrate CAP IR DR 40 MG ORAL
    HIC3 W1C
    HIC3 Description TETRACYCLINE ANTIBIOTICS
    GCN 27097
    HICL Sequence Number 004014
    HICL Sequence Number Description DOXYCYCLINE MONOHYDRATE
    Brand/Generic Brand
    Proprietary Name ORACEA
    Proprietary Name Suffix n/a
    Non-Proprietary Name DOXYCYCLINE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form CAPSULE
    Route ORAL
    Active Ingredient Strength 40
    Active Ingredient Units mg/1
    Substance Name DOXYCYCLINE
    Labeler Name Galderma Laboratories, L.P.
    Pharmaceutical Class Tetracycline-class Drug [EPC], Tetracyclines [CS]
    DEA Schedule n/a
    Marketing Category NDA
    Application Number NDA050805
    Listing Certified Through 2024-12-31

    Package

    NDC 00299-3822-02 (00299382202)

    NDC Package Code 0299-3822-02
    Billing NDC 00299382202
    Package 12 TRAY in 1 BOX (0299-3822-02) / 8 CARTON in 1 TRAY / 1 BLISTER PACK in 1 CARTON / 2 CAPSULE in 1 BLISTER PACK
    Marketing Start Date 2015-02-01
    NDC Exclude Flag N
    Pricing Information N/A