BENLYSTA- belimumab injection, powder, lyophilized, for solution
GlaxoSmithKline Manufacturing SpA

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PRINCIPLE DISPLAY PANEL

NDC 49401-101-01

Benlysta®

(belimumab)

for Injection

120 mg/vial

For Intravenous Infusion after dilution only. Single-dose vial.

Discard unused portion

Reconstitution:Reconstitute with 1.5 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL.

Dilute: Further dilute in 250 mL of one of the following solutions before use:

•: 0.9% Sodium Chloride Injection, USP
•: 0.45% Sodium Chloride Injection, USP
•: Lactated Ringer’s Injection, USP

Federal Law requires dispensing of BENLYSTA® with the Medication Guide provided with this carton.

Rx only

Rev. 6/16

10000000141921

PRINCIPAL DISPLAY PANEL

NDC 49401-102-01

Benlysta®

(belimumab)

for Injection

400 mg/vial

For Intravenous Infusion after dilution only. Single-dose vial.

Discard unused portion

Reconstitution:Reconstitute with 4.8 mL of Sterile Water for Injection, USP. After reconstitution, the concentration of BENLYSTA is 80 mg/mL.

Dilute: Further dilute in 250 mL of one of the following solutions before use:

•: 0.9% Sodium Chloride Injection, USP
•: 0.45% Sodium Chloride Injection, USP
•: Lactated Ringer’s Injection, USP

Federal Law requires dispensing of BENLYSTA® with the Medication Guide provided with this carton.

Rx only

Rev. 7/16

10000000141890

BENLYSTA
belimumab injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:12064-010
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BELIMUMAB (UNII: 73B0K5S26A) (BELIMUMAB - UNII:73B0K5S26A)	BELIMUMAB	400 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:12064-010-00	1 in 1 CARTON	03/10/2011
1		5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	BLA125370	03/10/2011

BENLYSTA
belimumab injection, powder, lyophilized, for solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:12064-009
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BELIMUMAB (UNII: 73B0K5S26A) (BELIMUMAB - UNII:73B0K5S26A)	BELIMUMAB	120 mg in 1.5 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:12064-009-00	1 in 1 CARTON	03/10/2011
1		1.5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Approved Drug Product Manufactured Under Contract	BLA125370	03/10/2011

Labeler - GlaxoSmithKline Manufacturing SpA (338471078)

Revised: 12/2017

Document Id: c25575a4-1e28-4d35-8acf-2e2d8743be37

Set id: 6fbb0330-d529-4cce-9b4a-006a89e30c6a

Version: 3

Effective Time: 20171204

GlaxoSmithKline Manufacturing SpA