The following Structured Product Label (SPL) was submitted to the FDA by Evonik Corporation for the product Gemcitabine Hydrochloride (NDC 62128-0383). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding on each inner pail. (generic) produced material label, shipping label on outer drum., (generic) warehouse weight label, may 2022 warehouse kg label, warehouse kg elma dec2022, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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 (Generic Produced Material Small)
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 (Gemcitabine Sept2017 Small)
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 (Generic Warehouse Kg Label Ecw Small)
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 (Gemcitabine Kg May2022)
Gemcitabine Hydrochloride
Put-away label
Material number: 99144329
Storage unit number
Net quantity: KG
QR Code
Lot/Batch number:
Old Material Number: QA383E
Storage Conditions: Warehouse Temperatur
Temperature condition: 8°C to 40°C
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) P (highly potent)
Evonik Corporation
1650 Lilly Road
Lafayette, Indiana 47909 USA
Phone: 765-477-4300
Fax: 765-477-4291
Evonik: Leading Beyond Chemistry
Emergency Phones (Chemtrec, 24 h)
US & CA 1-800-424-9300
Mexico 800-681-9531
Intl. 001-703-527-3887 (collect calls accepted)
Gemcitabine Warehouse Kg Elma Dec2022 (Kg Gemcitabine Qa383e Elma Dec2022)
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