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 NDC11-digit (billing)PackageCopy
0078-1483-20000781483200007814832060 TABLET in 1 BOTTLE (0078-1483-20)Marketed from Sep 30, 2025
0078-1483-9200078148392000781483922 BOTTLE in 1 CARTON (0078-1483-92) / 30 TABLET in 1 BOTTLEMarketed from Sep 30, 2025 · Sample package
0078-1483-93000781483930007814839330 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 CorporationNDC labeler code 0078
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 218436
Marketing start
Listing expires
Other FDA classes
Bruton's Tyrosine Kinase Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 0078-1483_03fb4b82-836d-4847-a9b5-e5695da55c1cSPL ID 03fb4b82-836d-4847-a9b5-e5695da55c1c
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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0078-1483

What is NDC 0078-1483?
0078-1483 is the product NDC for Rhapsido (remibrutinib), Remibrutinib 25 mg/1 tablet, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rhapsido (Remibrutinib).
What is the active ingredient?
Remibrutinib.
Who is the labeler?
Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rhapsido?
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.

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