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 | Type |
|---|---|---|---|
| BENLYSTA - GlaxoSmithKline LLC | GlaxoSmithKline LLC | 2026-08-21 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | 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 | 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 | 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 | 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 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rohto Cool Relief | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 | The Mentholatum Company | dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30 | 2026-06-19 | Warnings | 6OZP39ZG8H |
| 0.9% Sodium Chloride Saline Solution | SODIUM CHLORIDE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 546af257-dbd1-11fc-e063-6394a90a8e0a | 2026-06-16 | Warnings | 451W47IQ8X |
| ACD A | CITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATE | Terumo BCT, Ltd. | 395aec48-198a-4aed-8e38-7accfb3232f9 | 2026-06-15 | Warnings, Adverse reactions | 2968PHW8QP |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53f9c99a-0f20-0358-e063-6394a90af4e0 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5448c76a-2ecb-9402-e063-6294a90a6ad7 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | 451W47IQ8X |
| Male Support | AGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 29cefc89-3bb6-484e-84ab-116b5827a4c3 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5410ec88-8c65-3b26-e063-6294a90adf07 | 2026-06-12 | Warnings | 451W47IQ8X |
| V HP | ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR | Energique, Inc. | ea12ca3b-19e0-4d4a-9514-4d28d214e1e7 | 2026-06-12 | Warnings | 451W47IQ8X |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Cardinal Health 107, LLC | b3d5225c-0ee4-481e-b9ec-bc5e1321096d | 2026-06-12 | Adverse reactions | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 107af8bc-b6af-4b85-8c8a-ea757dcef1da | 2026-06-12 | Adverse reactions | 451W47IQ8X |
| GUNA-CELL | ACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINC | Guna spa | 90db80ed-c037-4e8f-a7f6-304a65f9fe22 | 2026-06-11 | Warnings | 2968PHW8QP |
| GUNA-MATRIX | ASCORBIC ACID - DODECAHYDROXYCYCLOHEXANE DIHYDRATE - FUCUS VESICULOSUS - HISTIDINE MONOHYDROCHLORIDE - HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED) - HYALURONIDASE - LACTIC ACID, DL - MALIC ACID - NADIDE - PHENYLALANINE - PRASTERONE - PROLACTIN - RANCID BEEF - SODIUM DIETHYL OXALACETATE - SODIUM PYRUVATE - SODIUM SULFATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE - THUJA OCCIDENTALIS TWIG - TYROSINE - | Guna spa | fa9ed512-97dc-44a2-b32d-86ca8c240532 | 2026-06-11 | Warnings | 1D5Q932XM6 |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 451W47IQ8X |
| GUNA-FLAM | ACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - | Guna spa | 7bda7eb0-8fd5-42d9-b336-39920bfc964d | 2026-06-10 | Warnings | 2968PHW8QP |
| GUNA-ALLERGY T | AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA - | Guna spa | fddba85e-2bec-468f-a01a-b71a3aeed9d3 | 2026-06-10 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d2c34e-fa4d-9240-e063-6294a90a28da | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO20 | CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d48847-c0bf-1334-e063-6294a90acf7e | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53d52b7e-1e84-d4d3-e063-6294a90a9efc | 2026-06-09 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.