Prescription drug · BLA
Yervoy (Ipilimumab) NDC 0003-2327
Ipilimumab 5 mg/mL · Injection · Intravenous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-2327-11 | 00003232711 | 1 VIAL, SINGLE-USE in 1 CARTON (0003-2327-11) / 10 mL in 1 VIAL, SINGLE-USEMarketed from Mar 25, 2011 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Yervoy
- Generic name (nonproprietary)
- ipilimumab
- Active ingredients
- Ipilimumab — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- E.R. Squibb & Sons, L.L.C.NDC labeler code 0003
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125377
- Marketing start
- Listing expires
- Other FDA classes
- CTLA-4-directed Antibody Interactions (Mechanism)Increased T Lymphocyte Activation (Physiologic effect)
- Identifiers
- Product ID 0003-2327_72755838-4a55-4245-949e-16cea13f2584SPL ID 72755838-4a55-4245-949e-16cea13f2584SPL set ID 2265ef30-253e-11df-8a39-0800200c9a66RxCUI 1657005, 1657007, 1657012, 1657013UNII 6T8C155666
- Pharmacologic class
- CTLA-4-directed Blocking Antibody
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
N400003232711followed by a unit qualifier and the quantityPackage 00003-2327-11. 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)
YERVOY is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for: Melanoma • Treatment of unresectable or metastatic melanoma in adults and pediatric patients 12 years and older as a single agent or in combination with nivolumab. (1.1) • Adjuvant treatment of adult patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. (1.2) Renal Cell Carcinoma (RCC) • Treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma, as first-line treatment in combination with nivolumab. (1.3) Colorectal Cancer • Treatment of adults and pe…
Excerpt only. Read the full label for complete information.
About NDC 0003-2327
- What is NDC 0003-2327?
- 0003-2327 is the product NDC for Yervoy (ipilimumab), Ipilimumab 5 mg/mL injection, listed with the FDA by E.R. Squibb & Sons, L.L.C.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Yervoy (Ipilimumab).
- What is the active ingredient?
- Ipilimumab.
- Who is the labeler?
- E.R. Squibb & Sons, L.L.C., NDC labeler code 0003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Yervoy?
- 1 other product NDC are listed under this name. See all Yervoy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Yervoy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Yervoyipilimumab | Ipilimumab 5 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-2328 | 00003-2328-22 |
Other NDCs under BLA 125377
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 |
|---|---|---|---|---|
| Yervoyipilimumab | Ipilimumab 5 mg/mL | InjectionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-2328 |