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
Label	Manufacturer	Effective date	Type
BENLYSTA - GlaxoSmithKline LLC	GlaxoSmithKline LLC	2026-08-21	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49401-088-01	BENLYSTA	1 mL in 1 SYRINGE	SOLUTION	1	37
49401-088-02	BENLYSTA	1 in 1 CARTON	SOLUTION	1	37
49401-088-35	BENLYSTA	4 in 1 CARTON	SOLUTION	4	37
49401-088-42	BENLYSTA	1 mL in 1 SYRINGE	SOLUTION	1	37
49401-088-47	BENLYSTA	4 in 1 CARTON	SOLUTION	4	37
49401-088-50	BENLYSTA	1 in 1 CARTON	SOLUTION	1	37
49401-088-61	BENLYSTA	1 mL in 1 SYRINGE	SOLUTION	1	37
49401-088-61	BENLYSTA	1 in 1 CARTON	SOLUTION	1	37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49401-088	BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC]	34	Current NDC, Legacy NDC, 8 package rows	20241220_2fa3c528-1777-4628-8a55-a69dae2381a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49401-088-01	ML - Milliliter	49401-088	bcf92992-9bad-464c-9d35-ac1a5039ded2	1	2017-08-11
49401-088-35	ML - Milliliter	49401-088	032d8042-004e-4b1c-ba71-6da76b6a2968	1	2017-08-11
49401-088-42	ML - Milliliter	49401-088	d29db4cf-ac8e-4023-83e0-f45c6c8669f5	1	2017-08-11
49401-088-47	ML - Milliliter	49401-088	1a653d99-ed2e-487f-9d87-c06f594b4217	1	2017-08-11
49401-088-61	ML - Milliliter	49401-088	81ce2c39-0bcf-4952-b030-94e59fee1108	1	2022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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 33 of 46 · 920 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	2024-04-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c1e52670-c85e-4f19-a2e9-bf9abd7c3727	2024-04-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Glyreg	ACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCA	Deseret Biologicals, Inc	28e670ca-ed35-4256-af20-74c25dc18099	2024-04-23	Warnings	Exact identifier unii: C151H8M554
Dermapar	EPIDERMIS (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, GRAPHITES, MEZEREUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PETROLEUM, RHUS TOX, SULPHUR, CAUSTICUM	Energique, Inc.	f79fe29b-341e-4bee-9665-1805a7157d1a	2024-04-22	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Hikma Pharmaceuticals USA Inc.	e5ee8caa-b6ca-45ba-98fb-8305e6282141	2024-04-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Hers Plus	CALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALIS	Deseret Biologicals,Inc.	e4636b80-f6c8-459c-8d0e-ff7801358b10	2024-04-09	Warnings	Exact identifier unii: 451W47IQ8X
R-Gene	ARGININE HYDROCHLORIDE	Pharmacia & Upjohn Company LLC	6accf33f-9841-4327-8923-93c42020ef12	2024-04-02	Warnings, Adverse reactions	Exact identifier unii: F7LTH1E20Y
SINU HC	PLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUM	Deseret Biologicals, Inc.	8b63e066-dd1b-4aee-a17b-4edc6b71a1cc	2024-04-02	Warnings	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	14931004-1efb-e331-e063-6294a90ad66e	2024-03-26	Warnings	Exact identifier unii: 451W47IQ8X
Aqua marina	SODIUM CHLORIDE	Boiron	14945760-30b5-27d3-e063-6394a90a8a32	2024-03-26		Exact identifier unii: 451W47IQ8X
Headache HP	BELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUM	Energique, Inc.	5dca8670-c931-47e3-af89-b5f09f5f4e02	2024-03-26	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	59ccc717-c374-41c0-be58-9647df881160	2024-03-26	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
V-Fem Care	AGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELIS	Newton Laboratories, Inc.	14800c19-e5c6-924b-e063-6394a90a15e5	2024-03-25	Warnings	Exact identifier unii: 451W47IQ8X
Control	ANACARDIUM ORIENTALE, AQUA MARINA, ARGENTUM NITRICUM, ASARUM CANADENSE, BLATTA ORIENTALIS, BUFO RANA, CEREBRUM SUIS, CLEMATIS ERECTA, CUPRUM ACETICUM, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PLACENTA TOTALIS SUIS, RHUS TOX, THUJA OCCIDENTALIS, THYMOLUM, VALERIANA OFFICINALIS	Deseret Biologicals, Inc.	9daec04d-44fb-4d0f-8e21-1109f515eb5d	2024-03-25	Warnings	Exact identifier unii: 451W47IQ8X
Grief	CIMICIFUGA RACEMOSA, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, SEPIA, CEREBRUM SUIS, IGNATIA AMARA, NATRUM MURIATICUM, AMBRA GRISEA, DNA, AURUM METALLICUM, COCCULUS INDICUS, DIGITALIS PURPUREA, HELLEBORUS NIGER, LYCOPODIUM CLAVATUM, STAPHYSAGRIA	Deseret Biologicals, Inc.	e7ff1297-512e-4e95-a918-1c57fa3a50dd	2024-03-25	Warnings	Exact identifier unii: 451W47IQ8X
Habit	CHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUS	Deseret Biologicals, Inc.	3d00a305-e15d-4419-97bd-332421d4a1b0	2024-03-15	Warnings	Exact identifier unii: C151H8M554
Bladder Kidney Meridian Opener	APIS MELLIFICA, ARGENTUM NITRICUM, BERBERIS VULGARIS, CANTHARIS, EQUISETUM ARVENSE, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, RHUS TOX, SEPIA, TEREBINTHINA, THUJA OCCIDENTALIS	Deseret Biologicals, Inc.	08e96657-9b15-41e3-88e5-8915cefb43be	2024-03-15	Warnings	Exact identifier unii: 451W47IQ8X
Breathe	ARGENTUM NITRICUM, NATRUM MURIATICUM, SULPHUR, ACONITUM NAPELLUS, ARSENICUM ALBUM, RHUS TOX, ADENOSINUM CYCLOPHOSPHORICUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, LUNG (SUIS), MUCOSA NASALIS SUIS, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, COUMARINUM, MALVIN, DYSENTERY BACILLUS, PROTEUS (MORGANI)	Deseret Biologicals, Inc	8dbdd623-a486-4cf8-acdb-ad051dc74348	2024-03-15	Warnings	Exact identifier unii: 451W47IQ8X
Leaky Gut Formula	ALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)	Deseret Biologicals, Inc.	7e3a254b-a43d-43a2-a777-0d0c0057e131	2024-03-14	Warnings	Exact identifier unii: C151H8M554
Balanced Salt	SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE	B. Braun Medical Inc.	74ab8883-0a5f-46b4-8998-9358f6fd4ef4	2024-03-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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