HYLENEX Recombinant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Halozyme, Inc.. The primary component is Hyaluronidase (human Recombinant).
| Product ID | 18657-117_308df247-a446-4284-8a1a-04410cd25e52 |
| NDC | 18657-117 |
| Product Type | Human Prescription Drug |
| Proprietary Name | HYLENEX Recombinant |
| Generic Name | Hyaluronidase (human Recombinant) |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2005-12-02 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021859 |
| Labeler Name | Halozyme, Inc. |
| Substance Name | HYALURONIDASE (HUMAN RECOMBINANT) |
| Active Ingredient Strength | 150 [USP'U]/mL |
| Pharm Classes | Endoglycosidase [EPC],Glycoside Hydrolases [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2005-12-02 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA |
| Application Number | NDA021859 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-12-02 |
| Marketing Category | NDA |
| Application Number | NDA021859 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-12-02 |
| Marketing Category | NDA |
| Application Number | NDA021859 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-12-02 |
| Marketing End Date | 2016-02-09 |
| Marketing Category | NDA |
| Application Number | NDA021859 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2005-12-02 |
| Ingredient | Strength |
|---|---|
| HYALURONIDASE (HUMAN RECOMBINANT) | 150 [USP'U]/mL |
| SPL SET ID: | 3023cc56-ed4b-4e87-b3a1-81b20943f658 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 18657-117 | HYLENEX Recombinant | Hyaluronidase (Human Recombinant) |
| 50090-4534 | HYLENEX Recombinant | Hyaluronidase (Human Recombinant) |