Prescription drug · BLA
Lymphir (Denileukin diftitox-cxdl) NDC 52658-7777
Denileukin diftitox 300 ug/2mL · Injection, Powder, Lyophilized, For solution · Intravenous · Citius Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52658-7777-1 | 52658777701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (52658-7777-1) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 1, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Lymphir
- Generic name (nonproprietary)
- denileukin diftitox-cxdl
- Active ingredients
- Denileukin diftitox — 300 ug/2mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Citius Pharmaceuticals, Inc.NDC labeler code 52658
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761312
- Marketing start
- Listing expires
- Other FDA classes
- Diphtheria Toxin (Chemical structure)Interleukin-2 (Chemical structure)Recombinant Fusion Proteins (Chemical structure)
- Identifiers
- Product ID 52658-7777_2c678496-2a12-3051-e063-6294a90a205eSPL ID 2c678496-2a12-3051-e063-6294a90a205eSPL set ID ac3613d7-4304-40e7-a3f5-adb8a8adca5dRxCUI 2700750, 2700756UNII 25E79B5CTM
- Pharmacologic class
- CD25-directed Cytotoxin
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
N452658777701followed by a unit qualifier and the quantityPackage 52658-7777-01. 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)
LYMPHIR is indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 52658-7777
- What is NDC 52658-7777?
- 52658-7777 is the product NDC for Lymphir (denileukin diftitox-cxdl), Denileukin diftitox 300 ug/2mL injection, powder, lyophilized, for solution, listed with the FDA by Citius Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lymphir (Denileukin diftitox-cxdl).
- What is the active ingredient?
- Denileukin diftitox.
- Who is the labeler?
- Citius Pharmaceuticals, Inc., NDC labeler code 52658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lymphir?
- 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.