VYVGART
- Product NDC
- 73475-3041
- 11-digit product format
- 734753041
- Labeler code
- 73475
- Product ID
- 73475-3041_3bce287a-2242-4c56-ba66-c06cc0eec56c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- EFGARTIGIMOD ALFA
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- argenx US
- Application
- BLA761195
- Marketing category
- BLA
- Marketing start
- 2021-12-17
- Substance
- EFGARTIGIMOD ALFA
- Active strength
- 20 mg/mL
- Pharmacologic classes
- 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
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFGARTIGIMOD ALFA | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 961YV2O515 |
| Rxcui | 2587723, 2587729 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73475-3041-5 | VYVGART | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 20 | | 15 |
| 73475-3041-5 | VYVGART | 1 in 1 CARTON | INJECTION | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73475-3041 | VYVGART (EFGARTIGIMOD ALFA) INJECTION [ARGENX US] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250413_8aefc8e3-26d6-4ff6-aab9-a7542927e084.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 73475-3041-5 | 73475304105 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73475-3041-5) / 20 mL in 1 VIAL, SINGLE-DOSE | 2021-12-17 | 0000-00-00 | No | No | Current |