Home DailyMed fbee39e8-5a15-4f61-b2fd-9cc71d59f855 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:12:17 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021560-001 ZORTRESS EVEROLIMUS 0.25MG TABLET / ORAL AB RLD 2010-04-20 N021560-002 ZORTRESS EVEROLIMUS 0.5MG TABLET / ORAL AB RLD 2010-04-20 N021560-003 ZORTRESS EVEROLIMUS 0.75MG TABLET / ORAL AB RLD 2010-04-20 N021560-004 ZORTRESS EVEROLIMUS 1MG TABLET / ORAL AB RLD 2018-08-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 172 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 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD 2018-08-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD 2018-08-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-001 5665772*PED 2020-03-09 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-002 5665772*PED 2020-03-09 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1049 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021560-003 5665772*PED 2020-03-09 Pediatric extension 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021560-001 5665772*PED 2020-03-09 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021560-002 5665772*PED 2020-03-09 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021560-003 5665772*PED 2020-03-09 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021560-001 5665772*PED 2020-03-09 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021560-002 5665772*PED 2020-03-09 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021560-003 5665772*PED 2020-03-09 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-001 5665772*PED 2020-03-09 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-002 5665772*PED 2020-03-09 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-003 5665772 2019-09-09 U-1049 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021560-003 5665772*PED 2020-03-09 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-001 5665772*PED 2020-03-09 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-002 5665772*PED 2020-03-09 Pediatric extension b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-003 5665772 2019-09-09 U-1049 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021560-003 5665772*PED 2020-03-09 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021560-001 5665772 2019-09-09 U-1365 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-001 5665772 2019-09-09 U-1049 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-001 5665772*PED 2020-03-09 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-002 5665772 2019-09-09 U-1365 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-002 5665772 2019-09-09 U-1049 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-002 5665772*PED 2020-03-09 Pediatric extension ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021560-003 5665772 2019-09-09 U-1365 Drug substance, Drug product ea99ee380514…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.