ATEBRIOZ
- Product NDC
- 79378-029
- 11-digit product format
- 793780029
- Labeler code
- 79378
- Product ID
- 79378-029_f542e4b0-072a-42c6-80c9-5977054971e0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- zilurgisertib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mirum Pharmaceuticals Inc.
- Application
- NDA221198
- Marketing category
- NDA
- Marketing start
- 2026-09-25
- Substance
- ZILURGISERTIB FUMARATE
- Active strength
- 25 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ATEBRIOZ
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZILURGISERTIB FUMARATE | 25 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 79378-029-16 | 79378002916 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79378-029-16) | 2026-09-25 | No | No | Current |