Prescription drug · BLA
Imlygic (Talimogene laherparepvec) NDC 55513-079
Talimogene laherparepvec 100000000 [PFU]/mL · Injection, Suspension · Intralesional · Amgen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-079-01 | 5551300790155513007901 | 1 VIAL in 1 CARTON (55513-079-01) / 1 mL in 1 VIALMarketed from Nov 2, 2015 |
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)
- Imlygic
- Generic name (nonproprietary)
- talimogene laherparepvec
- Active ingredients
- Talimogene laherparepvec — 100000000 [PFU]/mL
- Dosage form
- Injection, Suspension
- Route
- Intralesional
- Labeler
- Amgen IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125518
- Marketing start
- Listing expires
- Identifiers
- Product ID 55513-079_4d1843a8-7a83-4062-ba8c-4f97e2f1427bSPL ID 4d1843a8-7a83-4062-ba8c-4f97e2f1427bSPL set ID 64ffb680-ea8c-42fc-9649-9e8c0eb77ddbRxCUI 1721278, 1721283, 1721287, 1721289UNII 07730V90L6UPC 0355513079013, 0355513078016
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
N455513007901followed by a unit qualifier and the quantityPackage 55513-0079-01. 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)
IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 55513-079
- What is NDC 55513-079?
- 55513-079 is the product NDC for Imlygic (talimogene laherparepvec), Talimogene laherparepvec 100000000 [PFU]/mL injection, suspension, listed with the FDA by Amgen Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imlygic (Talimogene laherparepvec).
- What is the active ingredient?
- Talimogene laherparepvec.
- Who is the labeler?
- Amgen Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imlygic?
- 1 other product NDC are listed under this name. See all Imlygic NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imlygic products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under BLA 125518
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.