Prescription drug · BLA
Empliciti (Elotuzumab) NDC 0003-4522
Elotuzumab 400 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · E.R. Squibb & Sons, L.L.C.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0003-4522-11 | 0000345221100003452211 | 1 VIAL, SINGLE-USE in 1 CARTON (0003-4522-11) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USEMarketed from Nov 30, 2015 |
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)
- Empliciti
- Generic name (nonproprietary)
- elotuzumab
- Active ingredients
- Elotuzumab — 400 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- 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 761035
- Marketing start
- Listing expires
- Other FDA classes
- Monoclonal (Chemical structure)SLAMF7-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 0003-4522_8441efc2-338a-4d1d-8fa1-9b9863a49ffdSPL ID 8441efc2-338a-4d1d-8fa1-9b9863a49ffdSPL set ID 80686b7e-f6f4-4154-b5c0-c846425e2d91RxCUI 1726110, 1726115, 1726117, 1726119UNII 1351PE5UGSUPC 0300032291118
- Pharmacologic class
- SLAMF7-directed Immunostimulatory 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
N400003452211followed by a unit qualifier and the quantityPackage 00003-4522-11. 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)
• EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. EMPLICITI is a SLAMF7-directed immunostimulatory antibody indicated in • combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. (1) • combination with pomalidomide and dexamethasone for t…
Excerpt only. Read the full label for complete information.
About NDC 0003-4522
- What is NDC 0003-4522?
- 0003-4522 is the product NDC for Empliciti (elotuzumab), Elotuzumab 400 mg/1 injection, powder, lyophilized, for solution, 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?
- Empliciti (Elotuzumab).
- What is the active ingredient?
- Elotuzumab.
- 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 Empliciti?
- 1 other product NDC are listed under this name. See all Empliciti NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Empliciti products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Emplicitielotuzumab | Elotuzumab 300 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-2291 | 00003-2291-11 |
Other NDCs under BLA 761035
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 |
|---|---|---|---|---|
| Emplicitielotuzumab | Elotuzumab 300 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | E.R. Squibb & Sons, L.L.C. | 0003-2291 |