Zydelig

Product NDC: 61958-1701
11-digit product format: 619581701
Labeler code: 61958
Product ID: 61958-1701_ca3e7112-6dfe-403f-af6f-a0051e77d125
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: idelalisib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Gilead Sciences, Inc.
Application: NDA205858
Marketing category: NDA
Marketing start: 2014-07-23
Substance: IDELALISIB
Active strength: 100 mg/1
Pharmacologic classes: Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61958-1701-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61958-1701-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61958-1701-1	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205858-001	ZYDELIG	IDELALISIB	100MG	TABLET / ORAL	AB	RLD	2014-07-23
N205858-002	ZYDELIG	IDELALISIB	150MG	TABLET / ORAL	AB	RLD, RS	2014-07-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N205858-001	AB
N205858-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205858-001	9492449	2030-03-11	U-1914		2016-11-16
N205858-001	10730879	2033-03-05		Drug substance, Drug product	2020-09-03
N205858-001	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18
N205858-001	9469643	2033-09-02		Drug substance	2016-11-16
N205858-002	9492449	2030-03-11	U-1914		2016-11-16
N205858-002	10730879	2033-03-05		Drug substance, Drug product	2020-09-03
N205858-002	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18
N205858-002	9469643	2033-09-02		Drug substance	2016-11-16

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205858-001	ZYDELIG	100MG	TABLET / ORAL	RLD	2014-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205858-002	ZYDELIG	150MG	TABLET / ORAL	RLD, RS	2014-07-23	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205858-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205858-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 800 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205858-001	9492449	2030-03-11	U-1914		2016-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-001	10730879	2033-03-05		Drug substance, Drug product	2020-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-001	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-001	9469643	2033-09-02		Drug substance	2016-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-002	9492449	2030-03-11	U-1914		2016-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-002	10730879	2033-03-05		Drug substance, Drug product	2020-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-002	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205858-002	9469643	2033-09-02		Drug substance	2016-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	8980901	2025-05-12	U-1678		2015-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	9149477	2025-05-12	U-1757		2015-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	RE44599	2025-07-21	U-1558		2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	RE44599	2025-07-21	U-1615		2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	RE44638	2025-08-05		Drug substance, Drug product	2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	9492449	2030-03-11	U-1914		2016-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	10730879	2033-03-05		Drug substance, Drug product	2020-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-001	9469643	2033-09-02		Drug substance	2016-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	8980901	2025-05-12	U-1678		2015-04-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	9149477	2025-05-12	U-1757		2015-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	RE44599	2025-07-21	U-1615		2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	RE44599	2025-07-21	U-1558		2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	RE44638	2025-08-05		Drug substance, Drug product	2014-08-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	9492449	2030-03-11	U-1914		2016-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	10730879	2033-03-05		Drug substance, Drug product	2020-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205858-002	9469643	2033-09-02		Drug substance	2016-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205858-001	8980901	2025-05-12	U-1678		2015-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	9149477	2025-05-12	U-1757		2015-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	RE44599	2025-07-21	U-1558		2014-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	RE44599	2025-07-21	U-1615		2014-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	RE44638	2025-08-05		Drug substance, Drug product	2014-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	9492449	2030-03-11	U-1914		2016-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	10730879	2033-03-05		Drug substance, Drug product	2020-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	8865730	2033-03-05	U-1615	Drug substance, Drug product	2014-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-001	9469643	2033-09-02		Drug substance	2016-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-002	8980901	2025-05-12	U-1678		2015-04-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-002	9149477	2025-05-12	U-1757		2015-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-002	RE44599	2025-07-21	U-1615		2014-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-002	RE44599	2025-07-21	U-1558		2014-08-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205858-002	RE44638	2025-08-05		Drug substance, Drug product	2014-08-21	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205858-001	NCE	2019-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205858-001	ODE-70	2021-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205858-001	ODE-71	2021-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205858-002	NCE	2019-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205858-002	ODE-70	2021-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205858-002	ODE-71	2021-07-23	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N205858-001	ODE-70	2021-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205858-001	ODE-71	2021-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205858-002	ODE-70	2021-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N205858-002	ODE-71	2021-07-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205858-001	ODE-70	2021-07-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205858-001	ODE-71	2021-07-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205858-002	ODE-70	2021-07-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205858-002	ODE-71	2021-07-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205858-001	ODE-70	2021-07-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205858-001	ODE-71	2021-07-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205858-002	ODE-70	2021-07-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205858-002	ODE-71	2021-07-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205858-001	ODE-70	2021-07-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205858-001	ODE-71	2021-07-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205858-002	ODE-70	2021-07-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205858-002	ODE-71	2021-07-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205858-001	ODE-70	2021-07-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205858-001	ODE-71	2021-07-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205858-002	ODE-70	2021-07-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205858-002	ODE-71	2021-07-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205858-001	NCE	2019-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205858-001	ODE-70	2021-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205858-001	ODE-71	2021-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205858-002	NCE	2019-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205858-002	ODE-70	2021-07-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205858-002	ODE-71	2021-07-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205858-001	NCE	2019-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205858-001	ODE-70	2021-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205858-001	ODE-71	2021-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205858-002	NCE	2019-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205858-002	ODE-70	2021-07-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205858-002	ODE-71	2021-07-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205858-001	NCE	2019-07-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205858-001	ODE-70	2021-07-23	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zydelig
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IDELALISIB	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YG57I8T5M0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1544465	Internal RxNorm lookup
1544471	Internal RxNorm lookup
1544473	Internal RxNorm lookup
1544475	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
efbdafa9-d18c-4e85-b4a2-1e620fc74e50	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9373cbdc-ad8d-417c-9f7d-c1d9b46422bc	Product name	1	20141202

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61958-1701-1	2025-02-21	C162847	48780-1	2cef2736-ac38-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ZYDELIG safely and effectively. See full prescribing information for ZYDELIG. ZYDELIG® (idelalisib) tablets, for oral use Initial U.S. Approval: 2014
61958-1701-1	2025-01-30	C162847	48780-1	2cef2736-ac38-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ZYDELIG safely and effectively. See full prescribing information for ZYDELIG. ZYDELIG® (idelalisib) tablets, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-1701-1	Zydelig	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-1701-1	EA - Each	61958-1701	825decda-73f9-4849-b3e1-9633d23ec9c7	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IDELALISIB	ACTIVE INGREDIENT	YG57I8T5M0	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
IDELALISIB	ACTIVE MOIETY	YG57I8T5M0	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-1701	ZYDELIG (IDELALISIB) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	12	Current NDC, Legacy NDC, 1 package rows	20250223_efbdafa9-d18c-4e85-b4a2-1e620fc74e50.zip

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
Zydelig	IDELALISIB	Gilead Sciences, Inc.	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205858 application number: NDA205858 ndc (product): 61958-1701

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YG57I8T5M0	IDELALISIB	870281-82-6	IDELALISIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1544465	idelalisib 100 MG Oral Tablet	PSN	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544473	idelalisib 150 MG Oral Tablet	PSN	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544471	Zydelig 100 MG Oral Tablet	PSN	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544475	Zydelig 150 MG Oral Tablet	PSN	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544471	idelalisib 100 MG Oral Tablet [Zydelig]	SBD	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544475	idelalisib 150 MG Oral Tablet [Zydelig]	SBD	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544465	idelalisib 100 MG Oral Tablet	SCD	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544473	idelalisib 150 MG Oral Tablet	SCD	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544471	Zydelig 100 MG Oral Tablet	SY	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12
1544475	Zydelig 150 MG Oral Tablet	SY	efbdafa9-d18c-4e85-b4a2-1e620fc74e50	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61958-1701-1	61958170101	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1)	2014-07-23	0000-00-00	No	No	Current