RYZNEUTA
- Product NDC
- 72893-016
- 11-digit product format
- 728930016
- Labeler code
- 72893
- Product ID
- 72893-016_523867f4-dbc4-1258-e063-6394a90a3145
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- efbemalenograstim alfa-vuxw
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Acrotech Biopharma Inc
- Application
- BLA761134
- Marketing category
- BLA
- Marketing start
- 2023-11-23
- Substance
- EFBEMALENOGRASTIM ALFA
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Colony-Stimulating Factors [CS], Leukocyte Growth Factor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RYZNEUTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EFBEMALENOGRASTIM ALFA | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5UPW5HJW3O |
| Rxcui | 2670662, 2670669 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72893-016-02 | RYZNEUTA | 1 in 1 CARTON | INJECTION | 1 | | 7 |
| 72893-016-02 | RYZNEUTA | 1 mL in 1 SYRINGE | INJECTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72893-016 | RYZNEUTA (EFBEMALENOGRASTIM ALFA-VUXW) INJECTION [ACROTECH BIOPHARMA INC] | 4 | Current NDC, 2 package rows | 20241220_290ed754-758c-9cae-e063-6294a90ae68b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72893-016-02 | 72893001602 | 1 SYRINGE in 1 CARTON (72893-016-02) / 1 mL in 1 SYRINGE | 1 syringe | 2023-11-23 | No | No | Current |