ATEBRIOZ

Product NDC: 79378-029
Requested package NDC: 79378-029-16
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 · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N221198-001	ATEBRIOZ	ZILURGISERTIB FUMARATE	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2026-09-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N221198-001	ATEBRIOZ	EQ 25MG BASE	TABLET / ORAL		RLD, RS	2026-09-25	`c2088c7a36db…`

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