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 |
|---|---|---|---|---|---|---|
| Migo-Ease | ACONITUM NAP, LYCOPODIUM, NAT MUR, NUX VOM, PULSATILLA | Silver Star Brands | 816837f5-4487-657d-e053-2991aa0a78f4 | 2024-12-03 | Warnings | 451W47IQ8X |
| XX Health Pro | LACHESIS, NAT MUR, PULSATILLA, SEPIA, SULPHUR | Silver Star Brands | 4d11a65e-696a-0727-e054-00144ff88e88 | 2024-12-02 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d41602-9dcb-eaa8-e063-6394a90a7cfa | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | 451W47IQ8X |
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d5997b-1cae-41c2-e063-6394a90ac74a | 2024-11-26 | Warnings | 451W47IQ8X |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM | Energetix Corporation | 37063a49-6b45-4167-875d-49c9dac3f79b | 2024-11-20 | Warnings | 451W47IQ8X |
| Potassium Citrate and Citric Acid | POTASSIUM CITRATE AND CITRIC ACID MONOHYDRATE | PAI Holdings, LLC dba PAI Pharma | ce42122f-8087-471f-b0a3-5524bdbd4526 | 2024-11-19 | Warnings, Adverse reactions | 2968PHW8QP |
| TRICITRATES | POTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATE | PAI Holdings, LLC dba PAI Pharma | 2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad | 2024-11-15 | Warnings, Adverse reactions | 2968PHW8QP 1Q73Q2JULR |
| Sal de Uvas Picot | CITRIC ACID MONOHYDRATE AND SODIUM BICARBONATE | RB Health Mexico, S.A. de C.V. | 151b9bc9-1a6e-4401-ae58-4b4210ab4505 | 2024-11-15 | Warnings | 2968PHW8QP |
| Sodium Citrate and Citric Acid | SODIUM CITRATE AND CITRIC ACID MONOHYDRATE | Pharmaceutical Associates, Inc. | 63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5 | 2024-11-13 | Adverse reactions | 1Q73Q2JULR |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 99a15716-bbb9-4e33-a48d-20c58b81f392 | 2024-11-13 | 451W47IQ8X | |
| Focus | ADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUM | Deseret Biologicals, Inc. | e014e6b6-a07a-4170-b9af-f477da71597d | 2024-11-13 | Warnings | C151H8M554 |
| Itch Formula | ANTIPYRINUM, APIS MELLIFICA, CALENDULA OFFICINALIS, CANTHARIS, COPAIVA OFFICINALIS, CROTON TIGLIUM, GRAPHITES, HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, MEZEREUM, NATRUM MURIATICUM, PETROLEUM, RHUS VENENATA, STAPHYSAGRIA, SULPHUR, URTICA URENS | Deseret Biologicals, Inc. | 4dfb177b-bff3-4b6d-8fd9-cadd1df7812c | 2024-11-12 | Warnings | 451W47IQ8X |
| Plasma-Lyte 148 (pH 7.4) | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | fe935c8d-f42d-42e4-8665-0dc66829f231 | 2024-11-08 | 451W47IQ8X | |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | BECTON DICKINSON AND COMPANY | d3f90d2f-4536-4d32-800b-7a798f8a35db | 2024-11-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Hospira, Inc. | 8eb172da-dcd4-4660-4a8f-ad44a14b4af7 | 2024-11-06 | Adverse reactions | 451W47IQ8X |
| Licefreee Everyday | SODIUM CHLORIDE | Tec Laboratories,Inc. | 407b5fd6-2331-2ba7-e054-00144ff88e88 | 2024-11-05 | Warnings | 451W47IQ8X |
| Licefreee | HEAD LICE TREATMENT | Tec Laboratories, Inc. | 08c9d3dd-7177-0148-e054-00144ff8d46c | 2024-11-05 | Warnings | 451W47IQ8X |
| Bladder Relief | CAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS | Magni Company | 5d0db70c-6360-493b-bcf2-8dbc95314140 | 2024-11-05 | Warnings | 451W47IQ8X |
| Vaccines | ARNICA MONTANA, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MORBILLINUM, NATRUM MURIATICUM, SILICEA, SULPHUR IODATUM, THUJA OCCIDENTALIS, URTICA URENS | Liddell Laboratories, Inc. | 6e6e67d4-089e-4775-b4a4-5511953f6e3f | 2024-11-04 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.