BENLYSTA

Product NDC: 49401-088
11-digit product format: 494010088
Labeler code: 49401
Product ID: 49401-088_379d7f58-8f17-44b3-8336-6fe8ef015aed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: belimumab
Dosage form: SOLUTION
Route: SUBCUTANEOUS
Labeler: GlaxoSmithKline LLC
Application: BLA761043
Marketing category: BLA
Marketing start: 2017-07-20
Substance: BELIMUMAB
Active strength: 200 mg/mL
Pharmacologic classes: B Lymphocyte Stimulator-directed Antibody Interactions [MoA], B Lymphocyte Stimulator-specific Inhibitor [EPC], Decreased B Lymphocyte Activation [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: BENLYSTA
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BELIMUMAB	200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
73B0K5S26A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1656395	Internal RxNorm lookup
1656398	Internal RxNorm lookup
1656400	Internal RxNorm lookup
1656402	Internal RxNorm lookup
1939296	Internal RxNorm lookup
1939299	Internal RxNorm lookup
1939346	Internal RxNorm lookup
1939348	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2fa3c528-1777-4628-8a55-a69dae2381a3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2cc1dd89-5388-4737-a41d-2073e055fa56	Product name	2	20190716
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49401-088-01	BENLYSTA	1 mL in 1 SYRINGE	SOLUTION	1	37
49401-088-02	BENLYSTA	1 in 1 CARTON	SOLUTION	1	37
49401-088-35	BENLYSTA	4 in 1 CARTON	SOLUTION	4	37
49401-088-42	BENLYSTA	1 mL in 1 SYRINGE	SOLUTION	1	37
49401-088-47	BENLYSTA	4 in 1 CARTON	SOLUTION	4	37
49401-088-50	BENLYSTA	1 in 1 CARTON	SOLUTION	1	37
49401-088-61	BENLYSTA	1 mL in 1 SYRINGE	SOLUTION	1	37
49401-088-61	BENLYSTA	1 in 1 CARTON	SOLUTION	1	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49401-088-01	ML - Milliliter	49401-088	bcf92992-9bad-464c-9d35-ac1a5039ded2	1	2017-08-11
49401-088-35	ML - Milliliter	49401-088	032d8042-004e-4b1c-ba71-6da76b6a2968	1	2017-08-11
49401-088-42	ML - Milliliter	49401-088	d29db4cf-ac8e-4023-83e0-f45c6c8669f5	1	2017-08-11
49401-088-47	ML - Milliliter	49401-088	1a653d99-ed2e-487f-9d87-c06f594b4217	1	2017-08-11
49401-088-61	ML - Milliliter	49401-088	81ce2c39-0bcf-4952-b030-94e59fee1108	1	2022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BELIMUMAB	ACTIVE INGREDIENT	73B0K5S26A	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]	12
BELIMUMAB	ACTIVE MOIETY	73B0K5S26A	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]	12
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]	12
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]	12
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]	12
SUCROSE	INACTIVE INGREDIENT	C151H8M554	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49401-088	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC]	34	Current NDC, Legacy NDC, 8 package rows	20241220_2fa3c528-1777-4628-8a55-a69dae2381a3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENLYSTA	BELIMUMAB	GlaxoSmithKline LLC	2fa3c528-1777-4628-8a55-a69dae2381a3	2025-06-20	Warnings, Adverse reactions	Exact identifier application number: BLA761043 ndc (product): 49401-088

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761043	Benlysta	belimumab	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
73B0K5S26A	BELIMUMAB	356547-88-1	BELIMUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1656395	belimumab 120 MG Injection	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939296	belimumab 200 MG in 1 ML Auto-Injector	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939346	belimumab 200 MG in 1 ML Prefilled Syringe	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656400	belimumab 400 MG Injection	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656398	Benlysta 120 MG Injection	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939299	Benlysta 200 MG in 1 ML Auto-Injector	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939348	Benlysta 200 MG in 1 ML Prefilled Syringe	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656402	Benlysta 400 MG Injection	PSN	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939299	1 ML belimumab 200 MG/ML Auto-Injector [Benlysta]	SBD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939348	1 ML belimumab 200 MG/ML Prefilled Syringe [Benlysta]	SBD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656398	belimumab 120 MG Injection [Benlysta]	SBD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656402	belimumab 400 MG Injection [Benlysta]	SBD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939296	1 ML belimumab 200 MG/ML Auto-Injector	SCD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939346	1 ML belimumab 200 MG/ML Prefilled Syringe	SCD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656395	belimumab 120 MG Injection	SCD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656400	belimumab 400 MG Injection	SCD	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939299	1 ML Benlysta 200 MG/ML Auto-Injector	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939348	1 ML Benlysta 200 MG/ML Prefilled Syringe	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939296	belimumab 200 MG per 1 ML Auto-Injector	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939346	belimumab 200 MG per 1 ML Prefilled Syringe	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656398	Benlysta 120 MG Injection	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939299	Benlysta 200 MG per 1 ML Auto-Injector	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1939348	Benlysta 200 MG per 1 ML Prefilled Syringe	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37
1656402	Benlysta 400 MG Injection	SY	2fa3c528-1777-4628-8a55-a69dae2381a3	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49401-088-01	49401008801	1 mL in 1 SYRINGE	1 ml					Historical
49401-088-02	49401008802	1 SYRINGE in 1 CARTON (49401-088-02) / 1 mL in 1 SYRINGE (49401-088-01)	1 syringe	2017-07-20	0000-00-00	No	No	Current
49401-088-35	49401008835	4 SYRINGE in 1 CARTON (49401-088-35) / 1 mL in 1 SYRINGE (49401-088-01)	4 syringe	2017-07-20	0000-00-00	No	No	Current
49401-088-42	49401008842	1 mL in 1 SYRINGE	1 ml					Historical
49401-088-47	49401008847	4 SYRINGE in 1 CARTON (49401-088-47) / 1 mL in 1 SYRINGE (49401-088-42)	4 syringe	2017-07-20	0000-00-00	No	No	Current
49401-088-50	49401008850	1 SYRINGE in 1 CARTON (49401-088-50) / 1 mL in 1 SYRINGE (49401-088-42)	1 syringe	2017-07-20	0000-00-00	No	No	Current
49401-088-61	49401008861	1 SYRINGE in 1 CARTON (49401-088-61) / 1 mL in 1 SYRINGE	1 syringe	2020-06-02	0000-00-00	Yes	No	Current