benlysta

Generic: belimumab

Labeler: glaxosmithkline llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name benlysta
Generic Name belimumab
Labeler glaxosmithkline llc
Dosage Form SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

belimumab 200 mg/mL

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 49401-088
Product ID 49401-088_379d7f58-8f17-44b3-8336-6fe8ef015aed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761043
Listing Expiration 2027-12-31
Marketing Start 2017-07-20

Pharmacologic Class

Established (EPC)
b lymphocyte stimulator-specific inhibitor [epc]
Mechanism of Action
b lymphocyte stimulator-directed antibody interactions [moa]
Physiologic Effect
decreased b lymphocyte activation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49401088
Hyphenated Format 49401-088

Supplemental Identifiers

RxCUI
1656395 1656398 1656400 1656402 1939296 1939299 1939346 1939348
UNII
73B0K5S26A
NUI
N0000182156 N0000182637 N0000182636

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name benlysta (source: ndc)
Generic Name belimumab (source: ndc)
Application Number BLA761043 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (49401-088-02) / 1 mL in 1 SYRINGE (49401-088-01)
  • 4 SYRINGE in 1 CARTON (49401-088-35) / 1 mL in 1 SYRINGE (49401-088-01)
  • 4 SYRINGE in 1 CARTON (49401-088-47) / 1 mL in 1 SYRINGE (49401-088-42)
  • 1 SYRINGE in 1 CARTON (49401-088-50) / 1 mL in 1 SYRINGE (49401-088-42)
  • 1 SYRINGE in 1 CARTON (49401-088-61) / 1 mL in 1 SYRINGE
source: ndc

Packages (5)

49401-088-02 1 SYRINGE in 1 CARTON (49401-088-02) / 1 mL in 1 SYRINGE (49401-088-01) 49401-088-35 4 SYRINGE in 1 CARTON (49401-088-35) / 1 mL in 1 SYRINGE (49401-088-01) 49401-088-47 4 SYRINGE in 1 CARTON (49401-088-47) / 1 mL in 1 SYRINGE (49401-088-42) 49401-088-50 1 SYRINGE in 1 CARTON (49401-088-50) / 1 mL in 1 SYRINGE (49401-088-42) 49401-088-61 1 SYRINGE in 1 CARTON (49401-088-61) / 1 mL in 1 SYRINGE

Ingredients (1)

belimumab (200 mg/mL)

Linked Drug Pages (1)

BENLYSTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "379d7f58-8f17-44b3-8336-6fe8ef015aed", "openfda": {"nui": ["N0000182156", "N0000182637", "N0000182636"], "unii": ["73B0K5S26A"], "rxcui": ["1656395", "1656398", "1656400", "1656402", "1939296", "1939299", "1939346", "1939348"], "spl_set_id": ["2fa3c528-1777-4628-8a55-a69dae2381a3"], "pharm_class_pe": ["Decreased B Lymphocyte Activation [PE]"], "pharm_class_epc": ["B Lymphocyte Stimulator-specific Inhibitor [EPC]"], "pharm_class_moa": ["B Lymphocyte Stimulator-directed Antibody Interactions [MoA]"], "manufacturer_name": ["GlaxoSmithKline LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (49401-088-02)  / 1 mL in 1 SYRINGE (49401-088-01)", "package_ndc": "49401-088-02", "marketing_start_date": "20170720"}, {"sample": false, "description": "4 SYRINGE in 1 CARTON (49401-088-35)  / 1 mL in 1 SYRINGE (49401-088-01)", "package_ndc": "49401-088-35", "marketing_start_date": "20170720"}, {"sample": false, "description": "4 SYRINGE in 1 CARTON (49401-088-47)  / 1 mL in 1 SYRINGE (49401-088-42)", "package_ndc": "49401-088-47", "marketing_start_date": "20170720"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (49401-088-50)  / 1 mL in 1 SYRINGE (49401-088-42)", "package_ndc": "49401-088-50", "marketing_start_date": "20170720"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (49401-088-61)  / 1 mL in 1 SYRINGE", "package_ndc": "49401-088-61", "marketing_start_date": "20200602"}], "brand_name": "BENLYSTA", "product_id": "49401-088_379d7f58-8f17-44b3-8336-6fe8ef015aed", "dosage_form": "SOLUTION", "pharm_class": ["B Lymphocyte Stimulator-directed Antibody Interactions [MoA]", "B Lymphocyte Stimulator-specific Inhibitor [EPC]", "Decreased B Lymphocyte Activation [PE]"], "product_ndc": "49401-088", "generic_name": "belimumab", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENLYSTA", "active_ingredients": [{"name": "BELIMUMAB", "strength": "200 mg/mL"}], "application_number": "BLA761043", "marketing_category": "BLA", "marketing_start_date": "20170720", "listing_expiration_date": "20271231"}