Prescription drug · BLA
Elrexfio (Elranatamab-bcmm) NDC 63539-252
Elranatamab 44 mg/1.1mL · Injection, Solution · Subcutaneous · U.S. Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63539-252-02 | 6353902520263539025202 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63539-252-02) / 1.1 mL in 1 VIAL, SINGLE-DOSE (63539-252-01)Marketed from Aug 15, 2023 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Elrexfio
- Generic name (nonproprietary)
- elranatamab-bcmm
- Active ingredients
- Elranatamab — 44 mg/1.1mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- U.S. PharmaceuticalsNDC labeler code 63539
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761345
- Marketing start
- Listing expires
- Identifiers
- Product ID 63539-252_e5f013ba-4382-4ce2-8650-2ce23a5aaa5bSPL ID e5f013ba-4382-4ce2-8650-2ce23a5aaa5bSPL set ID aa044060-5b4b-4692-bf0f-9a50e140b10eRxCUI 2644885, 2644891UNII L0HR9A577V
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463539025202followed by a unit qualifier and the quantityPackage 63539-0252-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ELREXFIO is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T‑cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who ha…
Excerpt only. Read the full label for complete information.
About NDC 63539-252
- What is NDC 63539-252?
- 63539-252 is the product NDC for Elrexfio (elranatamab-bcmm), Elranatamab 44 mg/1.1mL injection, solution, listed with the FDA by U.S. Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Elrexfio (Elranatamab-bcmm).
- What is the active ingredient?
- Elranatamab.
- Who is the labeler?
- U.S. Pharmaceuticals, NDC labeler code 63539. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Elrexfio?
- 2 other product NDCs are listed under this name. See all Elrexfio NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Elrexfio products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Elrexfioelranatamab-bcmm | Elranatamab 44 mg/1.1mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-2522 | 00069-2522-02 |
| Elrexfioelranatamab-bcmm | Elranatamab 76 mg/1.9mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-4494 | 00069-4494-02 |
Other NDCs under BLA 761345
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Elrexfioelranatamab-bcmm | Elranatamab 44 mg/1.1mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-2522 |
| Elrexfioelranatamab-bcmm | Elranatamab 76 mg/1.9mL | Injection, SolutionSubcutaneous | Pfizer Laboratories Div Pfizer Inc | 0069-4494 |