Label: GEMCITABINE HYDROCHLORIDE powder

  • NDC Code(s): 62128-0383-1, 62128-0383-6
  • Packager: Evonik Corporation
  • Category: BULK INGREDIENT
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated June 10, 2022

If you are a consumer or patient please visit this version.

  • On each inner pail. (Generic) Produced Material Label

    For every pail, this label is applied:

    Produced Material Label

    Manufactured by:

    Evonik Corporation Tippecanoe Laboratories

    1650 Lilly Road, Lafayette, IN 47909 USA

    Order:

    Material Description:

    Item:

    Batch:

    Caution statement:

    Container number:

    (generic) produced material label

  • Shipping Label on Outer drum.

    Bulk for Export Only

    Caution: For Manufacturing, processing or repacking. Rx Only.

    Gemcitabine hydrochloride

    QA383E

    Caution: Toxic, skin permeable, mutagen, irritant (eyes), reproductive, and blood.

    Batch number:

    Manufacture date:

    Re-evaluation date:

    Manufactured and tested by Evonik Corporation, Tippecanoe Laboratories, 1650 Lilly Road, Lafayette, IN 47909

    Shipping label on outer drum

  • (generic) Warehouse weight label

    As the drum is weighed in the warehouse, this label is applied with the net weight and storage location:

    Material number:

    Material description:

    Batch:

    TO:

    SU: Storage unit

    Quantity: kg

    (generic) warehouse weight label

  • May 2022 Warehouse KG label

    Gemcitabine Hydrochloride

    Put-Away Label

    Material Number 99144329

    Storage Unit

    Net Weight xx Kg

    Lot/Batch

    Old Material Number QA383E

    QR code box

    Storage Conditions: Warehouse temperature

    Temperature Conditions: 8 to 40°C

    Hazards:

    Skin permeable. Mutagen. Irritant (eyes). Reproductive. Blood. Highly potent.

    Acute toxicity, oral. Acute toxicity, dermal.

    Health 2

    Fire 1

    Reactivity 1

    Special R (reproductive hazard)

    Evonik Corporation

    1650 Lilly Road Lafayette, Indiana 47909 USA

    Phone: 765-477-4300 Fax: 765-477-4291

    Evonik: Leading beyond Chemistry

    Emergency Information: Chemtrec 800-424-9300

    Warehouse_KG_May2022

  • INGREDIENTS AND APPEARANCE
    GEMCITABINE HYDROCHLORIDE 
    gemcitabine hydrochloride powder
    Product Information
    Product TypeBULK INGREDIENTItem Code (Source)NDC:62128-0383
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R) GEMCITABINE1 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62128-0383-13 in 1 DRUM05/01/1996
    115 kg in 1 PAIL
    2NDC:62128-0383-69 in 1 BOX05/01/1996
    29 kg in 1 PAIL
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only05/01/1996
    Labeler - Evonik Corporation (130890994)