Cellular therapy · BLA
Kymriah (Tisagenlecleucel) NDC 0078-0846
Tisagenlecleucel 2000000 1/1 · Injection, Suspension · Intravenous · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0846-19 | 00078084619 | 1 INJECTION, SUSPENSION in 1 BAG (0078-0846-19)Marketed from Aug 30, 2017 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Kymriah
- Generic name (nonproprietary)
- tisagenlecleucel
- Active ingredients
- Tisagenlecleucel — 2000000 1/1
- Dosage form
- Injection, Suspension
- Route
- Intravenous
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125646
- Marketing start
- Listing expires
- Other FDA classes
- CD19 Receptor Interactions (Mechanism)CD19-specific Chimeric Antigen Receptor (Chemical structure)Increased T Lymphocyte Activation (Physiologic effect)Genetically-modified (EXT)
- Identifiers
- Product ID 0078-0846_381f1ba3-f115-424f-9890-75eb06ab6666SPL ID 381f1ba3-f115-424f-9890-75eb06ab6666SPL set ID aad3ba54-dfd3-4cb3-9e2b-c5ef89559189RxCUI 1986442, 1986447, 2044973, 2044975UNII Q6C9WHR03O
- Pharmacologic class
- CD19-directed Chimeric Antigen Receptor; Genetically-modified Autologous T Cells
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
N400078084619followed by a unit qualifier and the quantityPackage 00078-0846-19. 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)
KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. ( 1.1 ) Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Limitations of Use : KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma. ( 1.2 ) Adult patients with relapsed or refractory follicular ly…
Excerpt only. Read the full label for complete information.
About NDC 0078-0846
- What is NDC 0078-0846?
- 0078-0846 is the product NDC for Kymriah (tisagenlecleucel), Tisagenlecleucel 2000000 1/1 injection, suspension, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Kymriah (Tisagenlecleucel).
- What is the active ingredient?
- Tisagenlecleucel.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kymriah?
- 1 other product NDC are listed under this name. See all Kymriah NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kymriah products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kymriahtisagenlecleucel | Tisagenlecleucel 60000000 1/1 | Injection, SuspensionIntravenous | Novartis Pharmaceuticals Corporation | 0078-0958 | 00078-0958-19 |
Other NDCs under BLA 125646
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 |
|---|---|---|---|---|
| Kymriahtisagenlecleucel | Tisagenlecleucel 60000000 1/1 | Injection, SuspensionIntravenous | Novartis Pharmaceuticals Corporation | 0078-0958 |