RAXIBACUMAB- raxibacumab injection 
Glaxo Operations UK Ltd

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PRINCIPAL DISPLAY PANEL

NDC 49401-104-01

RAXIBACUMAB

Injection

1700 mg/34mL

(50 mg/mL)

For Intravenous Infusion

Must be Diluted Prior To Use

Rx only

Single-Use Vial; Discard unused portion

ATTENTION: Confirm expiration date on carton prior to removing vial. Before use apply enclosed label to vial over the existing label.

34 mL

For Strategic National Stockpile Use Only

10000000115020 Rev. 3/13

Raxibacumab 34 mL vial carton

PRINCIPAL DISPLAY PANEL

NDC 49401-103-01

Raxibacumab

Injection

1700 mg/34mL

(50 mg/mL)

For Intravenous Infusion

Must be Diluted Prior To Use

Rx only

Single-Use Vial

Discard unused portion.

34 mL

Rev. 11/15

10000000137037

Raxibacumab 34 mL carton
RAXIBACUMAB 
raxibacumab injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-060
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAXIBACUMAB (UNII: 794PGL549S) (RAXIBACUMAB - UNII:794PGL549S) RAXIBACUMAB50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCINE (UNII: TE7660XO1C)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-060-001 in 1 CARTON03/23/2016
134 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 ContractBLA12534903/23/2016
RAXIBACUMAB 
raxibacumab injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63379-061
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RAXIBACUMAB (UNII: 794PGL549S) (RAXIBACUMAB - UNII:794PGL549S) RAXIBACUMAB50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCINE (UNII: TE7660XO1C)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SUCROSE (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63379-061-001 in 1 CARTON03/23/2016
134 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 ContractBLA12534903/23/2016
Labeler - Glaxo Operations UK Ltd (424738227)

Revised: 12/2017
 
Glaxo Operations UK Ltd