VYVGART Hytrulo
- Product NDC
- 73475-3102
- 11-digit product format
- 734753102
- Labeler code
- 73475
- Product ID
- 73475-3102_63be80ae-0be8-4da6-9c97-6c5c98ac9043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- efgartigimod alfa and hyaluronidase (human recombinant)
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- argenx US
- Application
- BLA761304
- Marketing category
- BLA
- Marketing start
- 2023-06-20
- Substance
- EFGARTIGIMOD ALFA; HYALURONIDASE (HUMAN RECOMBINANT)
- Active strength
- 180; 2000 mg/mL; U/mL
- Pharmacologic classes
- Endoglycosidase [EPC], Glycoside Hydrolases [CS], Neonatal Fc Receptor Blocker [EPC], Neonatal Fc Receptor Blockers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VYVGART Hytrulo
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFGARTIGIMOD ALFA | 180 mg/mL |
| HYALURONIDASE (HUMAN RECOMBINANT) | 2000 U/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 743QUY4VD8, 961YV2O515 |
| Rxcui | 2639951, 2639957, 2712083, 2712088 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73475-3102-3 | VYVGART Hytrulo | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 12 |
| 73475-3102-3 | VYVGART Hytrulo | 5.6 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5.6 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73475-3102 | VYVGART HYTRULO (EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT)) INJECTION, SOLUTION [ARGENX US] | 7 | Current NDC, 2 package rows | 20250418_7104d9e5-9910-47f5-9a93-741ac50f43b6.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 2712083 | efgartigimod alfa 1,000 MG / hyaluronidase-qvfc 10,000 UNT in 5 ML Prefilled Syringe | PSN | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639951 | efgartigimod alfa-hyaluronidase-qvfc 1008 MG / 11,200 UNT in 5.6 ML Injection | PSN | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2712088 | VYVGART Hytrulo 1,000 MG / 10,000 UNT in 5 ML Prefilled Syringe | PSN | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639957 | VYVGART Hytrulo 1008 MG / 11,200 UNT in 5.6 ML Injection | PSN | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2712088 | 5 ML efgartigimod alfa-qvfc 200 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Prefilled Syringe [Vyvgart Hytrulo] | SBD | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639957 | 5.6 ML efgartigimod alfa-qvfc 180 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Injection [Vyvgart Hytrulo] | SBD | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2712083 | 5 ML efgartigimod alfa-qvfc 200 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Prefilled Syringe | SCD | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639951 | 5.6 ML efgartigimod alfa-qvfc 180 MG/ML / hyaluronidase-qvfc 2000 UNT/ML Injection | SCD | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2712083 | efgartigimod alfa 1,000 MG / hyaluronidase-qvfc 10,000 UNT per 5 ML Prefilled Syringe | SY | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639951 | efgartigimod alfa-hyaluronidase-qvfc 1008 MG / 11,200 UNT per 5.6 ML Injection | SY | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639951 | efgartigimod alfa-qvfc 1008 MG / hyaluronidase-qvfc 11,200 UNT per 5.6 ML Injection | SY | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2712088 | Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc 1,000 MG / 10,000 UNT) per 5 ML Prefilled Syringe | SY | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639957 | Vyvgart Hytrulo (efgartigimod alfa-hyaluronidase-qvfc 1008 MG / 11,200 UNT) per 5.6 ML Injection | SY | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
| 2639957 | Vyvgart Hytrulo 1008 MG / 11,200 UNT per 5.6 ML Injection | SY | 7104d9e5-9910-47f5-9a93-741ac50f43b6 | 12 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 73475-3102-3 | 73475310203 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3102-3) / 5.6 mL in 1 VIAL, SINGLE-DOSE | 2023-06-20 | No | No | Current |