NDC Code(s) : 49401-102-01, 49401-101-01, 49401-088-42, 49401-088-47, 49401-088-50, 49401-088-01, 49401-088-35, 49401-088-02, 49401-088-61
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

BENLYSTAbelimumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49401-102
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELIMUMAB(UNII: 73B0K5S26A)
(BELIMUMAB - UNII:73B0K5S26A) 		BELIMUMAB400 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SUCROSE(UNII: C151H8M554)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49401-102-011 in 1 CARTON 03/10/2011
15 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125370 03/10/2011
BENLYSTAbelimumab INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49401-101
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELIMUMAB(UNII: 73B0K5S26A)
(BELIMUMAB - UNII:73B0K5S26A) 		BELIMUMAB120 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
SUCROSE(UNII: C151H8M554)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49401-101-011 in 1 CARTON 03/10/2011
11.5 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125370 03/10/2011
BENLYSTAbelimumab SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49401-088
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BELIMUMAB(UNII: 73B0K5S26A)
(BELIMUMAB - UNII:73B0K5S26A) 		BELIMUMAB200 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ARGININE HYDROCHLORIDE(UNII: F7LTH1E20Y)
HISTIDINE(UNII: 4QD397987E)
HISTIDINE MONOHYDROCHLORIDE(UNII: 1D5Q932XM6)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49401-088-474 in 1 CARTON 20/07/2017
1NDC:49401-088-421 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:49401-088-501 in 1 CARTON 20/07/2017
2NDC:49401-088-421 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:49401-088-354 in 1 CARTON 20/07/2017
3NDC:49401-088-011 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:49401-088-021 in 1 CARTON 20/07/2017
4NDC:49401-088-011 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
5NDC:49401-088-611 in 1 CARTON 06/02/2020
51 mL in 1 SYRINGE Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761043 07/20/2017

LABELER - GlaxoSmithKline LLC(167380711)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 49401-101-01

Benlysta

(belimumab)

for Injection

120 mg/vial

GSK

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.

Dilution: Further dilute to 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

©2022 GSK group of companies or its licensor.

Rev. 9/22

62000000082255

Benlysta 120 mg per vial carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 49401-102-01

Benlysta

(belimumab)

for Injection

400 mg/vial

GSK

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.

Dilution: Further dilute to 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

©2022 GSK group of companies or its licensor.

Rev. 9/22

62000000082242

Benlysta 400 mg per vial carton

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 49401-088-35

Benlysta

(belimumab)

Injection

200 mg/mL

Rx only

GSK

Once-weekly

For Subcutaneous Use

Contents:

  • • 4 Single-Dose 1-mL Prefilled Autoinjectors
  • • Instructions for Use (Read carefully)
  • • Medication Guide
  • • Prescribing Information

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

©2023 GSK group of companies or is licensor.

Rev. 4/23

62000000087694

Benlysta 200 mg-mL 4 count carton