Prescription drug · BLA
Imaavy (Nipocalimab-aahu) NDC 57894-800
Nipocalimab 185 mg/mL · Injection, Solution, Concentrate · Intravenous · Janssen Biotech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-800-01 | 57894080001 | 1 VIAL, SINGLE-DOSE in 1 BOX (57894-800-01) / 1.62 mL in 1 VIAL, SINGLE-DOSEMarketed from Apr 29, 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)
- Imaavy
- Generic name (nonproprietary)
- nipocalimab-aahu
- Active ingredients
- Nipocalimab — 185 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Janssen Biotech, Inc.NDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761430
- Marketing start
- Listing expires
- Identifiers
- Product ID 57894-800_38376edc-230b-4b2b-8bb6-55b9dccea7a5SPL ID 38376edc-230b-4b2b-8bb6-55b9dccea7a5SPL set ID 8886274c-f2b2-48af-85c1-2f90bfe304b8RxCUI 2712699, 2712706, 2712708, 2712709UNII 87M90CV8NC
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
N457894080001followed by a unit qualifier and the quantityPackage 57894-0800-01. 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)
IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of: generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. ( 1.1 ) warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. ( 1.2 ) 1.1 Generalized Myasthenia Gravis (gMG) IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kina…
Excerpt only. Read the full label for complete information.
About NDC 57894-800
- What is NDC 57894-800?
- 57894-800 is the product NDC for Imaavy (nipocalimab-aahu), Nipocalimab 185 mg/mL injection, solution, concentrate, listed with the FDA by Janssen Biotech, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imaavy (Nipocalimab-aahu).
- What is the active ingredient?
- Nipocalimab.
- Who is the labeler?
- Janssen Biotech, Inc., NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imaavy?
- 1 other product NDC are listed under this name. See all Imaavy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Imaavy products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Imaavynipocalimab-aahu | Nipocalimab 185 mg/mL | Injection, Solution, ConcentrateIntravenous | Janssen Biotech, Inc. | 57894-801 | 57894-0801-01 |
Other NDCs under BLA 761430
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 |
|---|---|---|---|---|
| Imaavynipocalimab-aahu | Nipocalimab 185 mg/mL | Injection, Solution, ConcentrateIntravenous | Janssen Biotech, Inc. | 57894-801 |