NDC 49401-088
BENLYSTA
Belimumab
BENLYSTA is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Human Genome Sciences, Inc.. The primary component is Belimumab.
| Product ID | 49401-088_0255ca36-fea3-46a1-b33a-88607d7d7064 |
| NDC | 49401-088 |
| Product Type | Human Prescription Drug |
| Proprietary Name | BENLYSTA |
| Generic Name | Belimumab |
| Dosage Form | Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2017-07-20 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761043 |
| Labeler Name | Human Genome Sciences, Inc. |
| Substance Name | BELIMUMAB |
| Active Ingredient Strength | 200 mg/mL |
| Pharm Classes | Decreased B Lymphocyte Activation [PE],B Lymphocyte Stimulator-specific Inhibitor [EPC],B Lymphocyte Stimulator-directed Antibody Interactions [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 49401-088-02
1 SYRINGE in 1 CARTON (49401-088-02) > 1 mL in 1 SYRINGE (49401-088-01)
| Marketing Start Date | 2017-07-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 49401-088-42 [49401008842]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-07-20 |
NDC 49401-088-01 [49401008801]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-07-20 |
NDC 49401-088-50 [49401008850]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-20 |
NDC 49401-088-02 [49401008802]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-20 |
NDC 49401-088-35 [49401008835]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-07-20 |
NDC 49401-088-47 [49401008847]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-07-20 |
NDC 49401-088-61 [49401008861]
BENLYSTA SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761043 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2020-06-02 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BELIMUMAB | 200 mg/mL |
OpenFDA Data
| SPL SET ID: | 2fa3c528-1777-4628-8a55-a69dae2381a3 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Decreased B Lymphocyte Activation [PE]
- B Lymphocyte Stimulator-specific Inhibitor [EPC]
- B Lymphocyte Stimulator-directed Antibody Interactions [MoA]
NDC Crossover Matching brand name "BENLYSTA" or generic name "Belimumab"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 49401-088 | BENLYSTA | belimumab |
| 49401-101 | BENLYSTA | belimumab |
| 49401-102 | BENLYSTA | belimumab |
Trademark Results [BENLYSTA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BENLYSTA 86538266 not registered Live/Pending |
GlaxoSmithKline Intellectual Property Limited 2015-02-18 |
 BENLYSTA 85235903 not registered Dead/Abandoned |
GLAXOSMITHKLINE INTELLECTUAL PROPERTY LIMITED 2011-02-07 |
 BENLYSTA 77979299 3797552 Live/Registered |
GLAXOSMITHKLINE INTELLECTUAL PROPERTY LIMITED 2006-12-04 |
 BENLYSTA 77924752 not registered Dead/Abandoned |
Human Genome Sciences, Inc. 2010-02-01 |
 BENLYSTA 77056582 not registered Dead/Abandoned |
Human Genome Sciences, Inc. 2006-12-04 |
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