Prescription drug · BLA
Zynlonta (Loncastuximab tesirine) NDC 79952-110
Loncastuximab tesirine 10 mg/2mL · Injection, Powder, Lyophilized, For solution · Intravenous · ADC Therapeutics America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79952-110-01 | 79952011001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (79952-110-01) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 30, 2021 |
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)
- Zynlonta
- Generic name (nonproprietary)
- loncastuximab tesirine
- Active ingredients
- Loncastuximab tesirine — 10 mg/2mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- ADC Therapeutics America, Inc.NDC labeler code 79952
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761196
- Marketing start
- Listing expires
- Identifiers
- Product ID 79952-110_6bd41585-62b9-4761-859b-759672bfd679SPL ID 6bd41585-62b9-4761-859b-759672bfd679SPL set ID af54af12-3edf-4301-8bc5-0446bc813c1dRxCUI 2540969, 2540974UNII 7K5O7P6QIUUPC 0379952110014
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
N479952011001followed by a unit qualifier and the quantityPackage 79952-0110-01. 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 .
Indications (excerpt from the label)
ZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ZYNLONTA is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory lar…
Excerpt only. Read the full label for complete information.
About NDC 79952-110
- What is NDC 79952-110?
- 79952-110 is the product NDC for Zynlonta (loncastuximab tesirine), Loncastuximab tesirine 10 mg/2mL injection, powder, lyophilized, for solution, listed with the FDA by ADC Therapeutics America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zynlonta (Loncastuximab tesirine).
- What is the active ingredient?
- Loncastuximab tesirine.
- Who is the labeler?
- ADC Therapeutics America, Inc., NDC labeler code 79952. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zynlonta?
- 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.