GEMCITABINE- gemcitabine hydrochloride injection, solution 
Mylan Laboratories Limited

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GEMCITABINE INJECTION

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-616-10

Gemcitabine Injection

200 mg/5.26 mL

(38 mg/mL)

For Intravenous Infusion Only

Must Be Diluted Before Use

CAUTION: CYTOTOXIC AGENT

Discard Unused Portion

Sterile

Mylan

Rx only

Single-Use Vial

Carton 200 mg

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-617-30

Gemcitabine Injection

1 g/26.3 mL

(38 mg/mL)

For Intravenous Infusion Only

Must Be Diluted Before Use

CAUTION: CYTOTOXIC AGENT

Discard Unused Portion

Sterile

Mylan

Rx only

Single-Use Vial

Carton 1g

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 67457-618-10

Gemcitabine Injection

2 g/52.6 mL

(38 mg/mL)

For Intravenous Infusion Only

Must Be Diluted Before Use

CAUTION: CYTOTOXIC AGENT

Discard Unused Portion

Sterile

Mylan

Rx only

Single-Use Vial

Carton 2g
GEMCITABINE 
gemcitabine hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47351-050
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R) GEMCITABINE38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47351-050-011 in 1 CARTON12/31/2017
15.26 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA20524212/31/2017
GEMCITABINE 
gemcitabine hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47351-078
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R) GEMCITABINE38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47351-078-301 in 1 CARTON12/31/2017
126.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA20524212/31/2017
GEMCITABINE 
gemcitabine hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:47351-079
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GEMCITABINE HYDROCHLORIDE (UNII: U347PV74IL) (GEMCITABINE - UNII:B76N6SBZ8R) GEMCITABINE38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47351-079-101 in 1 CARTON12/31/2017
152.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractANDA20524212/31/2017
Labeler - Mylan Laboratories Limited (650548014)

Revised: 11/2017
Document Id: 47314446-19dd-4939-8aa2-a79ded388519
Set id: 47314446-19dd-4939-8aa2-a79ded388519
Version: 1
Effective Time: 20171129
 
Mylan Laboratories Limited