Elrexfio
- Product NDC
- 63539-252
- 11-digit product format
- 635390252
- Labeler code
- 63539
- Product ID
- 63539-252_e5f013ba-4382-4ce2-8650-2ce23a5aaa5b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- elranatamab-bcmm
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- U.S. Pharmaceuticals
- Application
- BLA761345
- Marketing category
- BLA
- Marketing start
- 2023-08-15
- Substance
- ELRANATAMAB
- Active strength
- 44 mg/1.1mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Elrexfio
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELRANATAMAB | 44 mg/1.1mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L0HR9A577V |
| Rxcui | 2644885, 2644891 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-252-01 | Elrexfio | 1.1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1.1 | | 5 |
| 63539-252-02 | Elrexfio | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-252 | ELREXFIO (ELRANATAMAB-BCMM) INJECTION, SOLUTION [U.S. PHARMACEUTICALS] | 1 | Current NDC, 2 package rows | 20230817_aa044060-5b4b-4692-bf0f-9a50e140b10e.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 |
|---|
| 63539-252-01 | 63539025201 | 1.1 mL in 1 VIAL, SINGLE-DOSE | 1.1 ml | | | | Historical |
| 63539-252-02 | 63539025202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63539-252-02) / 1.1 mL in 1 VIAL, SINGLE-DOSE (63539-252-01) | | 2023-08-15 | Yes | No | Current |