DANYELZA
- Product NDC
- 73042-201
- 11-digit product format
- 730420201
- Labeler code
- 73042
- Product ID
- 73042-201_75b08b15-496c-4b4c-bf71-f0220b0d58b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naxitamab
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Y-mAbs Therapeutics, Inc.
- Application
- BLA761171
- Marketing category
- BLA
- Marketing start
- 2020-11-25
- Substance
- NAXITAMAB
- Active strength
- 40 mg/10mL
- Pharmacologic classes
- Glycolipid Disialoganglioside-directed Antibody Interactions [MoA], Glycolipid Disialoganglioside-directed Antibody [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DANYELZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAXITAMAB | 40 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9K8GNJ2874 |
| Rxcui | 2474239, 2474244 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73042-201-01 | DANYELZA | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 9 |
| 73042-201-01 | DANYELZA | 1 in 1 CARTON | INJECTION | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73042-201 | DANYELZA (NAXITAMAB) INJECTION [Y-MABS THERAPEUTICS, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250523_29a80c6b-8bad-4650-8c7f-f18490c868ec.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 |
|---|
| 73042-201-01 | 73042020101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (73042-201-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2020-11-25 | 0000-00-00 | No | No | Current |