JIDEYTRO

Product NDC: 85001-101
Requested package NDC: 85001-101-01
11-digit product format: 850010101
Labeler code: 85001
Product ID: 85001-101_6c672099-2978-474e-b783-973fe94efcfb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zidesamtinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Nuvalent, Inc.
Application: NDA220185
Marketing category: NDA
Marketing start: 2026-07-22
Substance: ZIDESAMTINIB
Active strength: 25 mg/1
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product: Yes
Brand name base: JIDEYTRO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZIDESAMTINIB	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MX5KQV5XHC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2748288	Internal RxNorm lookup
2748294	Internal RxNorm lookup
2748296	Internal RxNorm lookup
2748298	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
3760e421-b523-4d9b-e063-6394a90ab94b	Available on FDA.report

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JIDEYTRO	ZIDESAMTINIB	Nuvalent, Inc.	3760e421-b523-4d9b-e063-6394a90ab94b	2026-07-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 220185 application number: NDA220185 ndc (package): 85001-101-01 ndc (product): 85001-101 ndc11 (package): 85001010101

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
85001-101-01	85001010101	1 BOTTLE in 1 CARTON (85001-101-01) / 30 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2026-07-22	0	Current