Prescription drug · BLA
Enjaymo (Sutimlimab-jome) NDC 55292-820
Sutimlimab 50 mg/mL · Injection, Solution, Concentrate · Intravenous · Recordati Rare Diseases, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55292-820-01 | 55292082001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55292-820-01) / 22 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 25, 2025 |
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)
- Enjaymo
- Generic name (nonproprietary)
- sutimlimab-jome
- Active ingredients
- Sutimlimab — 50 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Recordati Rare Diseases, Inc.NDC labeler code 55292
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761164
- Marketing start
- Listing expires
- Other FDA classes
- Classical Complement Pathway Inhibitors (Mechanism)
- Identifiers
- Product ID 55292-820_fb86733b-25b0-48ca-97a0-8cb15eef1848SPL ID fb86733b-25b0-48ca-97a0-8cb15eef1848SPL set ID 0a25363a-7781-d9f8-cb1c-be22987bf03bRxCUI 2591419, 2591425UNII GNWE7KJ995
- Pharmacologic class
- Classical Complement Pathway Inhibitor
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
N455292082001followed by a unit qualifier and the quantityPackage 55292-0820-01. 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)
ENJAYMO is a classical complement inhibitor indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD). ( 1 ) Cold Agglutinin Disease ENJAYMO (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).
Excerpt only. Read the full label for complete information.
About NDC 55292-820
- What is NDC 55292-820?
- 55292-820 is the product NDC for Enjaymo (sutimlimab-jome), Sutimlimab 50 mg/mL injection, solution, concentrate, listed with the FDA by Recordati Rare Diseases, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Enjaymo (Sutimlimab-jome).
- What is the active ingredient?
- Sutimlimab.
- Who is the labeler?
- Recordati Rare Diseases, Inc., NDC labeler code 55292. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Enjaymo?
- 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.