Gemcitabine (Page 12 of 12)

Embryo-Fetal Toxicity

Advise females and males of reproductive potential that gemcitabine for injection can cause fetal harm. Advise females of reproductive potential to use effective contraception during treatment with gemcitabine for injection and for 6 months after the final dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with gemcitabine for injection and for 3 months after the final dose [see Warnings and Precaution (5.6), Use in Specific Populations (8.1, 8.3)].

Lactation

Advise women not to breastfeed during treatment with gemcitabine for injection and for at least one week after the last dose [see Use in Specific Populations (8.2)].

Infertility

Advise males of reproductive potential of the potential for reduced fertility with gemcitabine for injection [see Use in Specific Populations (8.3), Nonclinical Toxicology (13.1)].

Manufactured by:
THYMOORGAN PHARMAZIE GmbH
Schiffgraben 23, 38690 Goslar, Germany

Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922

Revised: December 2020

127.207.011/01

Pincipal Display Panel

NDC 0143-9394 -01 Rx only
Gemcitabine
for Injection, USP
200 mg per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial

vial
(click image for full-size original)

NDC 0143-9394 -01 Rx only
Gemcitabine
for Injection, USP
200 mg per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial

carton
(click image for full-size original)

Principal Display Panel

NDC 0143-9395 -01 Rx only
Gemcitabine
for Injection, USP
1 gram per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial

vial
(click image for full-size original)

NDC 0143-9395 -01 Rx only
Gemcitabine
for Injection, USP
1 gram per vial
For Intravenous use ONLY
Discard unused portionSterile Single-Dose Vial

carton
(click image for full-size original)

Representative Serialization Image

SI
(click image for full-size original)
GEMCITABINE gemcitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9394
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMCITABINE (Gemcitabine) GEMCITABINE 200 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol 200 mg
Sodium acetate 12.5 mg
Sodium hydroxide
Hydrochloric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9394-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9394-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206617 06/25/2021
GEMCITABINE gemcitabine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9395
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMCITABINE (GEMCITABINE) GEMCITABINE 1 g
Inactive Ingredients
Ingredient Name Strength
Mannitol 1 g
Sodium acetate 62.5 mg
Sodium hydroxide
Hydrochloric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9395-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0143-9395-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206617 06/25/2021
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 06/2021 Hikma Pharmaceuticals USA Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.