NDC codes

FDA NDC Directory
Product NDC (as listed)57894-111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57894-0111Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
57894-111-01578940111011 INJECTION, SUSPENSION in 1 BAG (57894-111-01)Marketed from Feb 28, 2022
57894-111-02578940111021 INJECTION, SUSPENSION in 1 BAG (57894-111-02)Marketed from Feb 28, 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)
Carvykti
Generic name (nonproprietary)
ciltacabtagene autoleucel
Active ingredients
Ciltacabtagene autoleucel — 100000000 1/1
Dosage form
Injection, Suspension
Route
Intravenous
Labeler
Janssen Biotech, Inc.NDC labeler code 57894
Product type
Cellular therapy
Marketing category
BLA — Biologics License ApplicationApplication BLA 125746
Marketing start
Listing expires
Identifiers
Product ID 57894-111_1bf2a69b-ca3c-40fc-8b19-df4f0caf4ef7SPL ID 1bf2a69b-ca3c-40fc-8b19-df4f0caf4ef7SPL set ID 7d040b91-3fb8-41db-ba7f-60a36f06e2c2RxCUI 2594780, 2594786, 2594789, 2594792UNII 0L1F17908Q

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.

How CPT relates to drug billing

NDC on a medical claim

N457894011101 followed by a unit qualifier and the quantity

Package 57894-0111-01. 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)

CARVYKTI is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. CARVYKTI is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57894-111

What is NDC 57894-111?
57894-111 is the product NDC for Carvykti (ciltacabtagene autoleucel), Ciltacabtagene autoleucel 100000000 1/1 injection, suspension, listed with the FDA by Janssen Biotech, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Carvykti (Ciltacabtagene autoleucel).
What is the active ingredient?
Ciltacabtagene autoleucel.
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 Carvykti?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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