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NDC 73475-3102-03 VYVGART Hytrulo 180; 2000 mg/mL; U/mL Details
VYVGART Hytrulo 180; 2000 mg/mL; U/mL
VYVGART Hytrulo is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by argenx US. The primary component is EFGARTIGIMOD ALFA; HYALURONIDASE (HUMAN RECOMBINANT).
Product Information
| NDC | 73475-3102 |
|---|---|
| Product ID | 73475-3102_b7cba729-876e-44e3-b497-cb77da05806f |
| Associated GPIs | |
| GCN Sequence Number | 084917 |
| GCN Sequence Number Description | efgartigimod-hyaluronidas-qvfc VIAL 1008MG/5.6 SUBCUT |
| HIC3 | Z29 |
| HIC3 Description | NEONATAL FC RECEPTOR (FCRN) INHIBITORS |
| GCN | 54327 |
| HICL Sequence Number | 049016 |
| HICL Sequence Number Description | EFGARTIGIMOD ALFA-HYALURONIDASE-QVFC |
| Brand/Generic | Brand |
| Proprietary Name | VYVGART Hytrulo |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | efgartigimod alfa and hyaluronidase (human recombinant) |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 180; 2000 |
| Active Ingredient Units | mg/mL; U/mL |
| Substance Name | EFGARTIGIMOD ALFA; HYALURONIDASE (HUMAN RECOMBINANT) |
| Labeler Name | argenx US |
| Pharmaceutical Class | Endoglycosidase [EPC], Glycoside Hydrolases [CS], Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761304 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 73475-3102-03 (73475310203)
| NDC Package Code | 73475-3102-3 |
|---|---|
| Billing NDC | 73475310203 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3) / 5.6 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2023-06-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |