NDC Code(s) : 47335-153-40, 47335-154-40
Packager : Sun Pharma Global FZE

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-153
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMCITABINE HYDROCHLORIDE(UNII: U347PV74IL)
(GEMCITABINE - UNII:B76N6SBZ8R) 		GEMCITABINE200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE(UNII: 4550K0SC9B)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MANNITOL(UNII: 3OWL53L36A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-153-401 in 1 CARTON 25/07/2011
15 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078433 07/25/2011 09/30/2018
GEMCITABINE GEMCITABINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47335-154
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GEMCITABINE HYDROCHLORIDE(UNII: U347PV74IL)
(GEMCITABINE - UNII:B76N6SBZ8R) 		GEMCITABINE1 g in 25 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE(UNII: 4550K0SC9B)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
MANNITOL(UNII: 3OWL53L36A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:47335-154-401 in 1 CARTON 25/07/2011
125 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078433 07/25/2011 11/30/2018

PRINCIPAL DISPLAY PANEL


NDC 47335-153-40
Gemcitabine For Injection USP
200 mg
(lyophilized)
For Intravenous Use Only
Sterile Single Use Vial
Rx only
gemcitabine-label-200mg

PRINCIPAL DISPLAY PANEL


NDC 47335-153-40
Gemcitabine For Injection USP
200 mg
(lyophilized)
For Intravenous Use Only
Sterile Single Use Vial
DO NOT REFRIGERATE
Rx only
SUN PHARMA
gemcitabine-carton-200mg

PRINCIPAL DISPLAY PANEL


NDC 47335-154-40
Gemcitabine For Injection USP
1 g
(lyophilized)
For Intravenous Use Only
Sterile Single Use Vial
Rx only
gemcitabine-label-1g

PRINCIPAL DISPLAY PANEL



NDC 47335-154-40
Gemcitabine For Injection USP
1 g
(lyophilized)
For Intravenous Use Only
Sterile Single Use Vial
DO NOT REFRIGERATE
Rx only
SUN PHARMA
gemcitabine-carton-1g