GEMCITABINE HYDROCHLORIDE powder

Gemcitabine hydrochloride by

Drug Labeling and Warnings

Gemcitabine hydrochloride by is a Other medication manufactured, distributed, or labeled by Evonik Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

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

(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

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 ELMa Dec2022

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)

INGREDIENTS AND APPEARANCE

GEMCITABINE HYDROCHLORIDE 
gemcitabine hydrochloride powder

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC: 62128-0383

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R)	GEMCITABINE	1 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62128-0383-1	3 in 1 DRUM	05/01/1996
1		15 kg in 1 PAIL
2	NDC: 62128-0383-6	9 in 1 BOX	05/01/1996
2		9 kg in 1 PAIL

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		05/01/1996

Labeler - Evonik Corporation (130890994)