Rhapsido (remibrutinib) NDC 0078-1483

NDC codes

FDA NDC Directory

Product NDC (as listed)0078-1483Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00078-1483Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
0078-1483-20	00078148320	60 TABLET in 1 BOTTLE (0078-1483-20)Marketed from Sep 30, 2025
0078-1483-92	00078148392	2 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLEMarketed from Sep 30, 2025 · Sample package
0078-1483-93	00078148393	30 TABLET in 1 BOTTLE (0078-1483-93)Marketed from Mar 23, 2026 · Sample package

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): Rhapsido
Generic name (nonproprietary): remibrutinib
Active ingredients: Remibrutinib — 25 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Novartis Pharmaceuticals Corporation
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 218436
Marketing start: Sep 30, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Bruton's Tyrosine Kinase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 0078-1483_9e44a793-9940-4ae3-9fe6-0f901afa37e0SPL ID 9e44a793-9940-4ae3-9fe6-0f901afa37e0SPL set ID e5e89bff-6ced-4165-acc5-fb13136b3a3dRxCUI 2724392, 2724398UNII I7MVZ8HDNU
Pharmacologic class: Kinase 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400078148320 followed by a unit qualifier and the quantity

Package 00078-1483-20. 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 Mar 23, 2026.

Indications (excerpt from the label)

RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria. RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. ( 1 ) Limitations of Use: Not indicated for other forms of urticaria. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)