Home NDC 0078-0417 Zortress
Product NDC 0078-0417
11-digit product format 000780417
Labeler code 0078
Product ID 0078-0417_5b9ba6f0-1e1d-4b9c-9122-ad856284d7ca
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 .25 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 42 .
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 · 168 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 2026-08-18 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-001 ZORTRESS 0.25MG TABLET / ORAL AB RLD 2010-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-002 ZORTRESS 0.5MG TABLET / ORAL AB RLD 2010-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-003 ZORTRESS 0.75MG TABLET / ORAL AB RLD 2010-04-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021560-004 ZORTRESS 1MG TABLET / ORAL AB RLD, RS 2018-08-10 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 160 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…
Additional Listing Data#
Finished product Yes
Brand name base Zortress
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS .25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9HW64Q8G6G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 977427 Internal RxNorm lookup 977431 Internal RxNorm lookup 977434 Internal RxNorm lookup 977436 Internal RxNorm lookup 977438 Internal RxNorm lookup 977440 Internal RxNorm lookup 2056895 Internal RxNorm lookup 2056897 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 0078-0417-20 Zortress 60 in 1 BOX TABLET 60 29 0078-0417-61 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 0078-0417 ZORTRESS (EVEROLIMUS) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION] 27 Current NDC, Legacy NDC, 2 package rows 20250105_e082a024-7850-400b-a5c2-2a140612562a.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 Zortress EVEROLIMUS Novartis Pharmaceuticals Corporation e082a024-7850-400b-a5c2-2a140612562a 2026-02-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021560 application number: NDA021560 ndc (product): 0078-0417
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 0078-0417-20 00078041720 60 BLISTER PACK in 1 BOX (0078-0417-20) / 1 TABLET in 1 BLISTER PACK (0078-0417-61) 60 blister pack 2010-04-22 0000-00-00 No No Current 0078-0417-61 00078041761 1 in 1 BLISTER PACK Historical