Prescription drug · BLA
Tecvayli (Teclistamab-cqyv) NDC 57894-450
Teclistamab 90 mg/mL · Injection · Subcutaneous · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-450-01 | 57894045001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (57894-450-01) / 1.7 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 25, 2022 |
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)
- Tecvayli
- Generic name (nonproprietary)
- teclistamab-cqyv
- Active ingredients
- Teclistamab — 90 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Janssen Biotech, Inc.NDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761291
- Marketing start
- Listing expires
- Identifiers
- Product ID 57894-450_5900ea09-1687-4d73-912f-5b0527cba6beSPL ID 5900ea09-1687-4d73-912f-5b0527cba6beSPL set ID 54e0f974-ccee-44ea-9254-40e9883cee1eRxCUI 2619432, 2619438, 2619441, 2619444UNII 54534MX6Z9
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
N457894045001followed by a unit qualifier and the quantityPackage 57894-0450-01. 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)
TECVAYLI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma in combination with daratumumab and hyaluronidase-fihj in patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. as monotherapy, in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody. TECVAYLI 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: in combination with daratumumab and hyaluronidase-fi…
Excerpt only. Read the full label for complete information.
About NDC 57894-450
- What is NDC 57894-450?
- 57894-450 is the product NDC for Tecvayli (teclistamab-cqyv), Teclistamab 90 mg/mL injection, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tecvayli (Teclistamab-cqyv).
- What is the active ingredient?
- Teclistamab.
- Who is the labeler?
- Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tecvayli?
- 1 other product NDC are listed under this name. See all Tecvayli NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tecvayli products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tecvayliteclistamab-cqyv | Teclistamab 10 mg/mL | InjectionSubcutaneous | Janssen Biotech, Inc. | 57894-449 | 57894-0449-01 |
Other NDCs under BLA 761291
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 |
|---|---|---|---|---|
| Tecvayliteclistamab-cqyv | Teclistamab 10 mg/mL | InjectionSubcutaneous | Janssen Biotech, Inc. | 57894-449 |