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 18 of 49 · 972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WALMART SALINESALINE NASAL (SODIUM CHLORIDE)WALMART STORES INC06906744-49a5-4bab-8539-af2d235df9e82025-10-28WarningsExact identifier
unii: 451W47IQ8X
SalineNASALPUBLIX SUPER MARKETS, INC19841567-9511-43d6-ba4e-d1e1bd3481a42025-10-28WarningsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts KALI MUR 6X 5KALI MURIATICUMZettl Health Inc.41ed34d0-94c3-ce79-e063-6294a90a08cb2025-10-24WarningsExact identifier
unii: 451W47IQ8X
NORMOSOL-M AND DEXTROSEDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATEICU Medical Inc.aba60c84-94d9-46d0-bdbb-25e0c4e8cc412025-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: 451W47IQ8X
Lactated RingersSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical Inc.b96eb740-749a-4d3a-ae63-b8e3947cad302025-10-23Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEMethod Pharmaceuticalsce84727a-3677-4bf0-e053-2995a90a3ec82025-10-21WarningsExact identifier
unii: 451W47IQ8X
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.2d212e10-7e08-4aeb-b63f-dcc9278977692025-10-17Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyca3355f2-2cf0-4f58-bed5-0c4c0a7d35112025-10-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: 451W47IQ8X
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: 451W47IQ8X
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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