Zydelig — Tablet, Film Coated

Overview

Brand name

Zydelig

Generic name

idelalisib

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

NDA · NDA

Labeler

Gilead Sciences, Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Idelalisib	100 mg/1	—	—
Idelalisib	150 mg/1	—	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated

Route of administration

Oral

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Cytochrome P450 3A Inhibitors [MoA]	MoA	All 89 members
Kinase Inhibitor [EPC]	EPC	All 89 members
Kinase Inhibitors [MoA]	MoA	All 10 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

205858

Application type

NDA · New Drug Application

Approval date

July 23, 2014

Sponsor

GILEAD SCIENCES INC

Products on application

2

Submissions recorded

15

Products approved under application 205858.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
205858-001	ZYDELIG	TABLET		IDELALISIB	Prescription	AB	RLD
205858-002	ZYDELIG	TABLET		IDELALISIB	Prescription	AB	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

AB

Reference Listed Drug

Yes

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Use code	Submitted
9492449	March 11, 2030	001	No	U-1914	November 16, 2016
9492449	March 11, 2030	002	No	U-1914	November 16, 2016
8865730	March 5, 2033	001	Yes	U-1615	November 18, 2014
10730879	March 5, 2033	001	Yes		September 3, 2020
8865730	March 5, 2033	002	Yes	U-1615	November 18, 2014
10730879	March 5, 2033	002	Yes		September 3, 2020
9469643	September 2, 2033	001	Yes		November 16, 2016
9469643	September 2, 2033	002	Yes		November 16, 2016

Approval history

Source: Drugs@FDA

Most recent submissions on application 205858.
Type	No.	Action	Status	Date	Review
Supplement	18	REMS	Approved	July 6, 2022	N/A
Supplement	17	REMS	Approved	March 10, 2022	N/A
Supplement	16	Labeling	Approved	February 18, 2022	Standard
Supplement	14	Labeling	Approved	October 19, 2020	Standard
Supplement	13	Labeling	Approved	October 10, 2018	Standard
Supplement	12	REMS	Approved	March 22, 2018	N/A
Supplement	10	REMS	Approved	February 6, 2018	N/A
Supplement	11	Labeling	Approved	February 2, 2018	Standard
Supplement	9	Labeling	Approved	January 26, 2018	Standard
Supplement	7	Labeling	Approved	November 29, 2017	Standard
Supplement	5	REMS	Approved	January 4, 2017	N/A
Supplement	4	Labeling	Approved	September 21, 2016	Standard
Supplement	3	Manufacturing (CMC)	Approved	January 19, 2016	Standard
Supplement	1	Manufacturing (CMC)	Approved	September 1, 2015	Standard
Original application	1	Type 1 - New Molecular Entity	Approved	July 23, 2014	Standard

Review documents

0 · Supplement · July 7, 2022
0 · Supplement · March 11, 2022
0 · Supplement · February 22, 2022
0 · Supplement · February 22, 2022
0 · Supplement · February 22, 2022
0 · Supplement · October 21, 2020
0 · Supplement · October 21, 2020
0 · Supplement · January 30, 2019
0 · Supplement · October 11, 2018
0 · Supplement · March 28, 2018
0 · Supplement · February 8, 2018
0 · Supplement · February 8, 2018
0 · Supplement · February 5, 2018
0 · Supplement · January 30, 2018
0 · Supplement · January 30, 2018
0 · Supplement · December 1, 2017
0 · Supplement · November 30, 2017
0 · Supplement · January 5, 2017
0 · Supplement · September 29, 2016
0 · Supplement · September 22, 2016
0 · Original application · February 6, 2015
0 · Original application · February 6, 2015
0 · Original application · July 24, 2014
0 · Original application · July 23, 2014

Adverse event reports

Source: openFDA FAERS

0

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
61958-1701-1	61958-1701	Gilead Sciences, Inc.	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)	July 23, 2014
61958-1702-1	61958-1702	Gilead Sciences, Inc.	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1)	July 23, 2014
61958-1701	61958-1701	Gilead Sciences, Inc.	—	July 23, 2014
61958-1702	61958-1702	Gilead Sciences, Inc.	—	July 23, 2014

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 10 sections on this page.