Prescription drug · BLA
Erbitux (Cetuximab) NDC 66733-948
Cetuximab 2 mg/mL · Solution · Intravenous · ImClone LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66733-948-23 | 66733094823 | 1 VIAL, SINGLE-DOSE in 1 CARTON (66733-948-23) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 12, 2004 |
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)
- Erbitux
- Generic name (nonproprietary)
- cetuximab
- Active ingredients
- Cetuximab — 2 mg/mL
- Dosage form
- Solution
- Route
- Intravenous
- Labeler
- ImClone LLCNDC labeler code 66733
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125084
- Marketing start
- Listing expires
- Other FDA classes
- HER1 Antagonists (Mechanism)
- Identifiers
- Product ID 66733-948_1cd448bd-5230-450c-ad4c-359e6d54cd2bSPL ID 1cd448bd-5230-450c-ad4c-359e6d54cd2bSPL set ID 8bc6397e-4bd8-4d37-a007-a327e4da34d9RxCUI 1657658, 1657660, 1657663, 1657664UNII PQX0D8J21J
- Pharmacologic class
- Epidermal Growth Factor Receptor Antagonist
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
N466733094823followed by a unit qualifier and the quantityPackage 66733-0948-23. 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)
ERBITUX ® is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of: Head and Neck Cancer Locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. ( 1.1 , 14.1 ) Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck in combination with platinum-based therapy with fluorouracil. ( 1.1 , 14.1 ) Recurrent or metastatic squamous cell carcinoma of the head and neck progressing after platinum-based therapy. ( 1.1 , 14.1 ) Colorectal Cancer K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with FOLFIRI for first-line…
Excerpt only. Read the full label for complete information.
About NDC 66733-948
- What is NDC 66733-948?
- 66733-948 is the product NDC for Erbitux (cetuximab), Cetuximab 2 mg/mL solution, listed with the FDA by ImClone LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erbitux (Cetuximab).
- What is the active ingredient?
- Cetuximab.
- Who is the labeler?
- ImClone LLC, NDC labeler code 66733. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Erbitux?
- 1 other product NDC are listed under this name. See all Erbitux NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erbitux products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Erbituxcetuximab | Cetuximab 2 mg/mL | SolutionIntravenous | ImClone LLC | 66733-958 | 66733-0958-23 |
Other NDCs under BLA 125084
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 |
|---|---|---|---|---|
| Erbituxcetuximab | Cetuximab 2 mg/mL | SolutionIntravenous | ImClone LLC | 66733-958 |