Home NDC 61958-1701 Zydelig
Product NDC 61958-1701
11-digit product format 619581701
Labeler code 61958
Product ID 61958-1701_131deed3-54eb-44c8-aab5-5e93c70db69f
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
Marketing end 2028-02-29
Substance IDELALISIB
Active strength 100 mg/1
Pharmacologic classes Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag No
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 43 .
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.
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 · 86 observed 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 2026-09-14 22:38:34 2026-08 N205858-001 ZYDELIG 100MG TABLET / ORAL AB RLD 2014-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 ZYDELIG 150MG TABLET / ORAL AB RLD, RS 2014-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205858-001 ZYDELIG 100MG TABLET / ORAL AB RLD 2014-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 ZYDELIG 150MG TABLET / ORAL AB RLD, RS 2014-07-23 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 21 · 816 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205858-001 9492449 2030-03-11 U-1914 2016-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-001 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-001 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-001 9469643 2033-09-02 Drug substance 2016-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 9492449 2030-03-11 U-1914 2016-11-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 10730879 2033-03-05 Drug substance, Drug product 2020-09-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 8865730 2033-03-05 U-1615 Drug substance, Drug product 2014-11-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205858-002 9469643 2033-09-02 Drug substance 2016-11-16 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 44 observed states.
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 Zydelig Active Ingredients# Ingredient, Strength table Ingredient Strength IDELALISIB 100 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
DailyMed RxNorm Mappings# 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 2028-02-29 No No Current