Prescription drug · BLA
Inmazeb NDC 61755-018
atoltivimab, maftivimab, and odesivimab-ebgn · Atoltivimab 241.7 mg/14.5mL + 2 more ingredients · Injection, Solution · Intravenous · Regeneron Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61755-018-01 | 61755001801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61755-018-01) / 14.5 mL in 1 VIAL, SINGLE-DOSE (61755-018-00)Marketed from Oct 14, 2020 |
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)
- Inmazeb
- Generic name (nonproprietary)
- atoltivimab, maftivimab, and odesivimab-ebgn
- Active ingredients
- Atoltivimab — 241.7 mg/14.5mLMaftivimab — 241.7 mg/14.5mLOdesivimab — 241.7 mg/14.5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Regeneron Pharmaceuticals, Inc.NDC labeler code 61755
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761169
- Marketing start
- Listing expires
- Identifiers
- Product ID 61755-018_03d5650a-82d9-4af5-9515-ea52c93733efSPL ID 03d5650a-82d9-4af5-9515-ea52c93733efSPL set ID 0536b6fe-6fe5-4fd6-8cc6-1b481945c1faRxCUI 2461536, 2461539, 2571682, 2571685UNII FJZ07Q63VY, KOP95331M4, UY9LQ8P6HW
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
N461755001801followed by a unit qualifier and the quantityPackage 61755-0018-01. 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)
INMAZEB is indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection [see Dosage and Administration (2.2) , and Clinical Studies (14) ] . INMAZEB is a combination of Orthoebolavirus zairense glycoprotein-directed human monoclonal antibodies (atoltivimab, maftivimab, and odesivimab), indicated for the treatment of infection caused by Orthoebolavirus zairense in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Orthoebolavirus zairense infection. ( 1 ) Limitation of Use The efficacy of INMAZEB has not bee…
Excerpt only. Read the full label for complete information.
About NDC 61755-018
- What is NDC 61755-018?
- 61755-018 is the product NDC for Inmazeb, Atoltivimab 241.7 mg/14.5mL + 2 more ingredients injection, solution, 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?
- Inmazeb (Atoltivimab, maftivimab, and odesivimab-ebgn).
- What is the active ingredient?
- Atoltivimab, Maftivimab, Odesivimab.
- 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 Inmazeb?
- 1 other product NDC are listed under this name. See all Inmazeb NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Inmazeb products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Inmazebatoltivimab, maftivimab, and odesivimab-ebgn | Atoltivimab 483.3 mg/14.5mL + 2 more ingredients | Injection, SolutionIntravenous | Regeneron Pharmaceuticals, Inc. | 61755-019 | 61755-0019-01 |
Other NDCs under BLA 761169
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 |
|---|---|---|---|---|
| Inmazebatoltivimab, maftivimab, and odesivimab-ebgn | Atoltivimab 483.3 mg/14.5mL + 2 more ingredients | Injection, SolutionIntravenous | Regeneron Pharmaceuticals, Inc. | 61755-019 |