Prescription drug · BLA
Libtayo (Cemiplimab-rwlc) NDC 61755-008
Cemiplimab 50 mg/mL · Injection · Intravenous · Regeneron Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61755-008-01 | 61755000801 | 1 VIAL, SINGLE-USE in 1 CARTON (61755-008-01) / 7 mL in 1 VIAL, SINGLE-USEMarketed from Sep 28, 2018 |
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)
- Libtayo
- Generic name (nonproprietary)
- cemiplimab-rwlc
- Active ingredients
- Cemiplimab — 50 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Regeneron Pharmaceuticals, Inc.NDC labeler code 61755
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761097
- Marketing start
- Listing expires
- Identifiers
- Product ID 61755-008_024fbfcd-06aa-44d2-ae90-1aa59f65425cSPL ID 024fbfcd-06aa-44d2-ae90-1aa59f65425cSPL set ID 4347ae1f-d397-4f18-8b70-03897e1c054aRxCUI 2058830, 2058835UNII 6QVL057INT
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
N461755000801followed by a unit qualifier and the quantityPackage 61755-0008-01. 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)
LIBTAYO is a programmed death receptor-1 (PD-1) blocking antibody indicated: Cutaneous Squamous Cell Carcinoma (CSCC) for the treatment of adult patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. ( 1.1 ) for the adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation. ( 1.1 , 14.1 ) Basal Cell Carcinoma (BCC) for the treatment of adult patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. ( 1.2 …
Excerpt only. Read the full label for complete information.
About NDC 61755-008
- What is NDC 61755-008?
- 61755-008 is the product NDC for Libtayo (cemiplimab-rwlc), Cemiplimab 50 mg/mL injection, listed with the FDA by Regeneron Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Libtayo (Cemiplimab-rwlc).
- What is the active ingredient?
- Cemiplimab.
- Who is the labeler?
- Regeneron Pharmaceuticals, Inc., NDC labeler code 61755. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Libtayo?
- 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.