Home NDC 0078-0422 Zortress
Product NDC 0078-0422
11-digit product format 000780422
Labeler code 0078
Product ID 0078-0422_ade28559-5fac-4dfd-a56c-c453ceb9e30b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name everolimus
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA021560
Marketing category NDA
Marketing start 2010-04-22
Substance EVEROLIMUS
Active strength 1 mg/1
Pharmacologic classes Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 176 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 2026-10-15 13:18:30 2026-09 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD 2018-08-10 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 168 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.
Additional Listing Data#
Finished product Yes
Brand name base Zortress
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS 1 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 0078-0422-20 Zortress 60 in 1 BOX TABLET 60 29 0078-0422-61 Zortress 1 in 1 BLISTER PACK TABLET 1 29
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0422 ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 27 Current NDC, Legacy NDC, 2 package rows 20250105_e082a024-7850-400b-a5c2-2a140612562a.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0422-20 00078042220 60 BLISTER PACK in 1 BOX (0078-0422-20) / 1 TABLET in 1 BLISTER PACK (0078-0422-61) 60 blister pack 2018-08-10 0000-00-00 No No Current 0078-0422-61 00078042261 1 in 1 BLISTER PACK Historical