Home NDC 49401-101 BENLYSTA
Product NDC 49401-101
11-digit product format 494010101
Labeler code 49401
Product ID 49401-101_379d7f58-8f17-44b3-8336-6fe8ef015aed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name belimumab
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler GlaxoSmithKline LLC
Application BLA125370
Marketing category BLA
Marketing start 2011-03-10
Substance BELIMUMAB
Active strength 120 mg/1.5mL
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 120 mg/1.5mL
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49401-101-01 BENLYSTA 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 37 49401-101-01 BENLYSTA 1.5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1.5 37
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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 49401-101 BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC] 34 Current NDC, Legacy NDC, 2 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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125370 Benlysta belimumab 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49401-101-01 49401010101 1 VIAL in 1 CARTON (49401-101-01) / 1.5 mL in 1 VIAL 1 vial 2011-03-10 0000-00-00 No No Current