Search by Drug Name or NDC

    NDC 69097-0552-03 DIMETHYL FUMARATE Details

    DIMETHYL FUMARATE

    DIMETHYL FUMARATE is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Cipla USA Inc.. The primary component is .

    Product Information

    NDC 69097-0552
    Product ID 69097-552_6dfb9c9b-7f8a-49a4-8e01-4b214282412f
    Associated GPIs 62405525006320
    GCN Sequence Number 070785
    GCN Sequence Number Description dimethyl fumarate CAPSULE DR 120-240 MG ORAL
    HIC3 H0E
    HIC3 Description AGENTS TO TREAT MULTIPLE SCLEROSIS
    GCN 34433
    HICL Sequence Number 040168
    HICL Sequence Number Description DIMETHYL FUMARATE
    Brand/Generic Generic
    Proprietary Name DIMETHYL FUMARATE
    Proprietary Name Suffix n/a
    Non-Proprietary Name DIMETHYL FUMARATE
    Product Type HUMAN PRESCRIPTION DRUG
    Dosage Form KIT
    Route n/a
    Active Ingredient Strength n/a
    Active Ingredient Units n/a
    Substance Name n/a
    Labeler Name Cipla USA Inc.
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category ANDA
    Application Number ANDA210305
    Listing Certified Through 2025-12-31

    Package

    NDC 69097-0552-03 (69097055203)

    NDC Package Code 69097-552-03
    Billing NDC 69097055203
    Package 1 KIT in 1 KIT (69097-552-03) * 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC * 46 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC
    Marketing Start Date 2020-09-24
    NDC Exclude Flag N
    Pricing Information N/A