Prescription drug · NDA
Atebrioz (Zilurgisertib) NDC 79378-029
Zilurgisertib fumarate 25 mg/1 · Tablet, Film coated · Oral · Mirum Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79378-029-16 | 7937800291679378002916 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79378-029-16)Marketed from Sep 25, 2026 |
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)
- Atebrioz
- Generic name (nonproprietary)
- zilurgisertib
- Active ingredients
- Zilurgisertib fumarate — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mirum Pharmaceuticals Inc.NDC labeler code 79378
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 221198
- Marketing start
- Listing expires
- Identifiers
- Product ID 79378-029_f542e4b0-072a-42c6-80c9-5977054971e0SPL ID f542e4b0-072a-42c6-80c9-5977054971e0
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
N479378002916followed by a unit qualifier and the quantityPackage 79378-0029-16. 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 79378-029
- What is NDC 79378-029?
- 79378-029 is the product NDC for Atebrioz (zilurgisertib), Zilurgisertib fumarate 25 mg/1 tablet, film coated, listed with the FDA by Mirum Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atebrioz (Zilurgisertib).
- What is the active ingredient?
- Zilurgisertib fumarate.
- Who is the labeler?
- Mirum Pharmaceuticals Inc., NDC labeler code 79378. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atebrioz?
- 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.