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 10 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Comfort Flow Sinus washSINUS WASHWALMART INC9e911eef-ca99-9902-e053-2a95a90aab0e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
EQUATE PREMIUM SALINESODIUM CHLORIDE 0.65%Walmart Stores, Inc.1e17f022-f513-140d-e063-6394a90a379e2026-01-19WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEFresenius Kabi USA, LLCd98bf9f7-30ec-4927-a577-cabad192cb182026-01-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
unii: 451W47IQ8X
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: 451W47IQ8X
LuffaLUFFA, HYDRASTIS CANADENSIS, MERCURIUS SULPH. RUB, ALLIUM CEPA, NATRUM MURITICUM, PHOSPHORUS, EUPATORIUM PERF, STICTAMarco Pharma International LLC.7dbb79de-c3f5-4245-884a-a6bd29bb861c2026-01-12WarningsExact identifier
unii: 451W47IQ8X
Hepaticol Drops 5008HEPATICOL DROPSProfessional Complementary Health Formulas79ee9e37-7853-4560-a87d-cdaefb603bbb2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Weight Management Formula 7534WEIGHT MANAGEMENT FORMULAProfessional Complementary Health Formulasf0406b63-7b97-4b2c-b976-75e8890818c62026-01-08WarningsExact identifier
unii: 451W47IQ8X
Acne Drops 2001ACNE DROPSProfessional Complementary Health Formulas340fc7dc-2aa4-411f-842b-4ce7046717222026-01-08WarningsExact identifier
unii: 451W47IQ8X
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: 451W47IQ8X
Viral Immune Stimulator 6017VIRAL IMMUNE STIMULATORProfessional Complementary Health Formulasf462cfb7-e1c3-4ded-9f79-f1983517fe152026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pituitary Liquescence 3018PITUITARY LIQUESCENCEProfessional Complementary Health Formulasa32e9ea9-5ff9-4951-9244-7b3253456b5f2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Psorinum Combination 9237PSORINUM COMBINATIONProfessional Complementary Health Formulas8b2a133d-9681-4091-a6d1-4ecc4583626b2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Adrenal Liquescence 3001ADRENAL LIQUESCENCEProfessional Complementary Health Formulas0388d3c7-4b3b-4e74-8c1b-9a2af2a4377d2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anti-Constipation Drops 2077ANTI-CONSTIPATION DROPSProfessional Complementary Health Formulas55d105fe-5698-43a6-9252-eaa9b63299d02026-01-08WarningsExact identifier
unii: 451W47IQ8X
Anxious Drops 2098ANXIOUS DROPSProfessional Complementary Health Formulasa5dc8619-074a-4c1f-8bb2-fea788f5aff12026-01-08WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus Liquescence 3023SPLEEN THYMUS LIQUESCENCEProfessional Complementary Health Formulasabe3c5c4-c5b4-47dd-afe3-b7858c82f7752026-01-08WarningsExact identifier
unii: 451W47IQ8X
RET Bladder 7006RET BLADDERProfessional Complementary Health Formulasf1d354e7-3d72-40aa-aaf1-172cb39f07112026-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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