FDA.reportPublic FDA data

NDC 49401-088-01 - BENLYSTA

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49401-088
Requested NDC
49401-088-01
Package NDCs from labels
49401-088-42, 49401-088-47, 49401-088-50, 49401-088-01, 49401-088-35, 49401-088-02, 49401-088-61
Manufacturer
GlaxoSmithKline LLC
Effective date
2026-08-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BENLYSTA - GlaxoSmithKline LLCGlaxoSmithKline LLC2026-08-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49401-088-01BENLYSTA1 mL in 1 SYRINGESOLUTION137
49401-088-02BENLYSTA1 in 1 CARTONSOLUTION137
49401-088-35BENLYSTA4 in 1 CARTONSOLUTION437
49401-088-42BENLYSTA1 mL in 1 SYRINGESOLUTION137
49401-088-47BENLYSTA4 in 1 CARTONSOLUTION437
49401-088-50BENLYSTA1 in 1 CARTONSOLUTION137
49401-088-61BENLYSTA1 mL in 1 SYRINGESOLUTION137
49401-088-61BENLYSTA1 in 1 CARTONSOLUTION137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49401-088BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC]34Current NDC, Legacy NDC, 8 package rows20241220_2fa3c528-1777-4628-8a55-a69dae2381a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49401-088-01ML - Milliliter49401-088bcf92992-9bad-464c-9d35-ac1a5039ded212017-08-11
49401-088-35ML - Milliliter49401-088032d8042-004e-4b1c-ba71-6da76b6a296812017-08-11
49401-088-42ML - Milliliter49401-088d29db4cf-ac8e-4023-83e0-f45c6c8669f512017-08-11
49401-088-47ML - Milliliter49401-0881a653d99-ed2e-487f-9d87-c06f594b421712017-08-11
49401-088-61ML - Milliliter49401-08881ce2c39-0bcf-4952-b030-94e59fee110812022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BELIMUMABACTIVE INGREDIENT73B0K5S26ABENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
BELIMUMABACTIVE MOIETY73B0K5S26ABENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
SUCROSEINACTIVE INGREDIENTC151H8M554BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12

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 11 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 451W47IQ8X
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
L-Histidine High 7410L-HISTIDINE HIGHProfessional Complementary Health Formulas7eec7d23-236f-4770-9587-1bf602fd91c22026-01-08WarningsExact identifier
unii: 4QD397987E
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 451W47IQ8X
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Cell Salt Combination 8013CELL SALT COMBINATIONProfessional Complementary Health Formulasb3a33345-3c3d-4f86-ae4d-757c65fd1ed32026-01-08WarningsExact identifier
unii: 451W47IQ8X
Shingles Nosode 4028SHINGLES NOSODEProfessional Complementary Health Formulase71d917a-af9f-41e9-a3de-cb588db7e0222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Immune System Stimulator Drops 2033IMMUNE SYSTEM STIMULATOR DROPSProfessional Complementary Health Formulasf4595c63-1c9c-48a6-a13a-3659991f455b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Gallbladder 7007RET GALLBLADDERProfessional Complementary Health Formulas82bc7b50-aea3-4993-b171-919940fef2972026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Pituitary/Sex 7012RET PITUITARY/SEXProfessional Complementary Health Formulas5081185c-1598-4bf5-b47b-b15135c453fb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Melancholy Drops Extrovert 2015MELANCHOLY DROPS EXTROVERTProfessional Complementary Health Formulas2c9187ce-a52e-445e-a36e-fe374f5ad2e22026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Lung 7003RET LUNGProfessional Complementary Health Formulas2ed03832-f226-4b3c-9ee6-5352f8d79fdb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.