NDC 50242-108
Rituxan Hycela
Rituximab And Hyaluronidase
Rituxan Hycela is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Rituximab; Hyaluronidase (human Recombinant).
| Product ID | 50242-108_1d917dd9-67b3-4f8c-8875-d3d383e06362 |
| NDC | 50242-108 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Rituxan Hycela |
| Generic Name | Rituximab And Hyaluronidase |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2017-06-22 |
| Marketing Category | BLA / BLA |
| Application Number | BLA761064 |
| Labeler Name | Genentech, Inc. |
| Substance Name | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
| Active Ingredient Strength | 120 mg/mL; U/mL |
| Pharm Classes | CD20-directed Antibody Interactions [MoA],CD20-directed Cytolytic Antibody [EPC],Endoglycosidase [EPC],Glycoside Hydrolases [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 50242-108-01
1 VIAL, SINGLE-DOSE in 1 CARTON (50242-108-01) > 11.7 mL in 1 VIAL, SINGLE-DOSE
| Marketing Start Date | 2017-06-22 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 50242-108-01 [50242010801]
Rituxan Hycela INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761064 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-06-22 |
NDC 50242-108-86 [50242010886]
Rituxan Hycela INJECTION, SOLUTION
| Marketing Category | BLA |
| Application Number | BLA761064 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-23 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| RITUXIMAB | 120 mg/mL |
OpenFDA Data
| SPL SET ID: | 3e5b7e82-f018-4eaf-ae78-d6145a906b20 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- CD20-directed Antibody Interactions [MoA]
- CD20-directed Cytolytic Antibody [EPC]
- Endoglycosidase [EPC]
- Glycoside Hydrolases [CS]
NDC Crossover Matching brand name "Rituxan Hycela" or generic name "Rituximab And Hyaluronidase"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 50242-108 | Rituxan Hycela | rituximab and hyaluronidase |
| 50242-109 | Rituxan Hycela | rituximab and hyaluronidase |
Trademark Results [Rituxan Hycela]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RITUXAN HYCELA 87264875 5298229 Live/Registered |
Biogen MA Inc. 2016-12-12 |
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