FDA.reportPublic FDA data

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 · source snapshot 45.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N221198-001ATEBRIOZZILURGISERTIB FUMARATEEQ 25MG BASETABLET / ORALRLD, RS2026-09-25

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N221198-001107109802037-07-18Drug substance, Drug product2026-10-09
N221198-001109472182037-07-18U-46262026-10-09
N221198-001124668082039-05-24U-4626Drug substance, Drug product2026-10-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N221198-001NCE2031-09-25

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10N221198-001ATEBRIOZEQ 25MG BASETABLET / ORALRLD, RS2026-09-25d4dbc9d85df4…
2026-10-15 13:18:302026-09N221198-001ATEBRIOZEQ 25MG BASETABLET / ORALRLD, RS2026-09-25c2088c7a36db…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-11-14 07:37:172026-10N221198-001107109802037-07-18Drug substance, Drug product2026-10-09d4dbc9d85df4…
2026-11-14 07:37:172026-10N221198-001109472182037-07-18U-46262026-10-09d4dbc9d85df4…
2026-11-14 07:37:172026-10N221198-001124668082039-05-24U-4626Drug substance, Drug product2026-10-09d4dbc9d85df4…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-11-14 07:37:172026-10N221198-001NCE2031-09-25d4dbc9d85df4…

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
IngredientStrength
ZILURGISERTIB FUMARATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1R349830SBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2754652Internal RxNorm lookup
2754658Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f542e4b0-072a-42c6-80c9-5977054971e0Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
79378-029-1679378002916120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (79378-029-16) 2026-09-25NoNoCurrent