Prescription drug · BLA
Rystiggo (rozanolixizumab) NDC 50474-983
Rozanolixizumab 140 mg/mL · Injection, Solution · Subcutaneous · UCB, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50474-983-86 | 50474098386 | 1 VIAL, GLASS in 1 CARTON (50474-983-86) / 6 mL in 1 VIAL, GLASSMarketed from Jul 15, 2024 |
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)
- Rystiggo
- Generic name (nonproprietary)
- rozanolixizumab
- Active ingredients
- Rozanolixizumab — 140 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- UCB, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761286
- Marketing start
- Listing expires
- Other FDA classes
- Neonatal Fc Receptor Blockers (Mechanism)
- Identifiers
- Product ID 50474-983_48d5f5c1-c45c-cb63-e063-6394a90a31c8SPL ID 48d5f5c1-c45c-cb63-e063-6394a90a31c8SPL set ID 3c0eb8c2-c042-4954-b451-3baa77f5e6d1RxCUI 2642288, 2642294, 2685614, 2685615, 2685616, 2685617, 2685618, 2685619UNII P7186074QC
- Pharmacologic class
- Neonatal Fc Receptor Blocker
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
N450474098386followed by a unit qualifier and the quantityPackage 50474-0983-86. 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)
RYSTIGGO is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. RYSTIGGO (rozanolixizumab-noli) is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761286
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 |
|---|---|---|---|---|
| Rystiggorozanolixizumab | Rozanolixizumab 140 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-980 |
| Rystiggorozanolixizumab | Rozanolixizumab 140 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-981 |
| Rystiggorozanolixizumab | Rozanolixizumab 140 mg/mL | Injection, SolutionSubcutaneous | UCB, Inc. | 50474-982 |