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 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

belimumab 120 mg/1.5mL

Manufacturer
GlaxoSmithKline LLC

Identifiers & Regulatory

Product NDC 49401-101
Product ID 49401-101_379d7f58-8f17-44b3-8336-6fe8ef015aed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125370
Listing Expiration 2027-12-31
Marketing Start 2011-03-10

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 49401101
Hyphenated Format 49401-101

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 BLA125370 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 120 mg/1.5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (49401-101-01) / 1.5 mL in 1 VIAL
source: ndc

Packages (1)

49401-101-01 1 VIAL in 1 CARTON (49401-101-01) / 1.5 mL in 1 VIAL

Ingredients (1)

belimumab (120 mg/1.5mL)

Linked Drug Pages (1)

BENLYSTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "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 VIAL in 1 CARTON (49401-101-01)  / 1.5 mL in 1 VIAL", "package_ndc": "49401-101-01", "marketing_start_date": "20110310"}], "brand_name": "BENLYSTA", "product_id": "49401-101_379d7f58-8f17-44b3-8336-6fe8ef015aed", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["B Lymphocyte Stimulator-directed Antibody Interactions [MoA]", "B Lymphocyte Stimulator-specific Inhibitor [EPC]", "Decreased B Lymphocyte Activation [PE]"], "product_ndc": "49401-101", "generic_name": "belimumab", "labeler_name": "GlaxoSmithKline LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BENLYSTA", "active_ingredients": [{"name": "BELIMUMAB", "strength": "120 mg/1.5mL"}], "application_number": "BLA125370", "marketing_category": "BLA", "marketing_start_date": "20110310", "listing_expiration_date": "20271231"}