Home NDC 0078-0567 Afinitor
Product NDC 0078-0567
11-digit product format 000780567
Labeler code 0078
Product ID 0078-0567_79d3253f-e1e3-428f-8dd4-4f2fe76faa15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name everolimus
Dosage form TABLET
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA022334
Marketing category NDA
Marketing start 2009-03-31
Substance EVEROLIMUS
Active strength 10 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 N022334-001 AFINITOR EVEROLIMUS 5MG TABLET / ORAL AB RLD, RS 2009-03-30 N022334-002 AFINITOR EVEROLIMUS 10MG TABLET / ORAL AB RLD 2009-03-30 N022334-003 AFINITOR EVEROLIMUS 2.5MG TABLET / ORAL AB RLD 2010-07-09 N022334-004 AFINITOR EVEROLIMUS 7.5MG TABLET / ORAL AB RLD 2012-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022334-001 8410131 2025-11-01 U-1368 2013-04-02 N022334-001 8410131*PED 2026-05-01 Pediatric extension N022334-001 9006224 2028-07-01 U-1681 2015-04-20 N022334-002 8410131 2025-11-01 U-1368 2013-04-02 N022334-002 8410131*PED 2026-05-01 Pediatric extension N022334-002 9006224 2028-07-01 U-1681 2015-04-20 N022334-003 8410131 2025-11-01 U-1368 2013-04-02 N022334-003 8410131*PED 2026-05-01 Pediatric extension N022334-003 9006224 2028-07-01 U-1681 2015-04-20 N022334-004 8410131 2025-11-01 U-1368 2013-04-02 N022334-004 8410131*PED 2026-05-01 Pediatric extension N022334-004 9006224 2028-07-01 U-1681 2015-04-20
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 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022334-001 AFINITOR 5MG TABLET / ORAL AB RLD, RS 2009-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022334-002 AFINITOR 10MG TABLET / ORAL AB RLD 2009-03-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022334-003 AFINITOR 2.5MG TABLET / ORAL AB RLD 2010-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022334-004 AFINITOR 7.5MG TABLET / ORAL AB RLD 2012-03-30 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 154 observed states.
Observed Orange Book patent history# Patent history page 1 of 23 · 888 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022334-001 8410131 2025-11-01 U-1368 2013-04-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-001 8410131*PED 2026-05-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-001 9006224 2028-07-01 U-1681 2015-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-002 8410131 2025-11-01 U-1368 2013-04-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-002 8410131*PED 2026-05-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-002 9006224 2028-07-01 U-1681 2015-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-003 8410131 2025-11-01 U-1368 2013-04-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-003 8410131*PED 2026-05-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-003 9006224 2028-07-01 U-1681 2015-04-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-004 8410131 2025-11-01 U-1368 2013-04-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-004 8410131*PED 2026-05-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022334-004 9006224 2028-07-01 U-1681 2015-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022334-001 8410131 2025-11-01 U-1368 2013-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-001 8410131*PED 2026-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-001 9006224 2028-07-01 U-1681 2015-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-002 8410131 2025-11-01 U-1368 2013-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-002 8410131*PED 2026-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-002 9006224 2028-07-01 U-1681 2015-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-003 8410131 2025-11-01 U-1368 2013-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-003 8410131*PED 2026-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-003 9006224 2028-07-01 U-1681 2015-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-004 8410131 2025-11-01 U-1368 2013-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-004 8410131*PED 2026-05-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022334-004 9006224 2028-07-01 U-1681 2015-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-001 8410131 2025-11-01 U-1368 2013-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-001 8410131*PED 2026-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-001 9006224 2028-07-01 U-1681 2015-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-002 8410131 2025-11-01 U-1368 2013-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-002 8410131*PED 2026-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-002 9006224 2028-07-01 U-1681 2015-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-003 8410131 2025-11-01 U-1368 2013-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-003 8410131*PED 2026-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-003 9006224 2028-07-01 U-1681 2015-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-004 8410131 2025-11-01 U-1368 2013-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-004 8410131*PED 2026-05-01 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022334-004 9006224 2028-07-01 U-1681 2015-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022334-001 8410131 2025-11-01 U-1368 2013-04-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022334-001 8410131*PED 2026-05-01 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022334-001 9006224 2028-07-01 U-1681 2015-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022334-002 8410131 2025-11-01 U-1368 2013-04-02 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 144 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Afinitor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EVEROLIMUS 10 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 · 14 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 845507 Internal RxNorm lookup 845512 Internal RxNorm lookup 845515 Internal RxNorm lookup 845518 Internal RxNorm lookup 998189 Internal RxNorm lookup 998191 Internal RxNorm lookup 1119400 Internal RxNorm lookup 1119402 Internal RxNorm lookup 1308428 Internal RxNorm lookup 1308430 Internal RxNorm lookup 1308432 Internal RxNorm lookup 1310138 Internal RxNorm lookup 1310144 Internal RxNorm lookup 1310147 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 0078-0567-51 Afinitor 28 in 1 CARTON TABLET 28 66 0078-0567-61 Afinitor 1 in 1 BLISTER PACK TABLET 1 66
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EVEROLIMUS ACTIVE INGREDIENT 9HW64Q8G6G AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 EVEROLIMUS ACTIVE MOIETY 9HW64Q8G6G AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 MANNITOL INACTIVE INGREDIENT 3OWL53L36A AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 34
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0567 AFINITOR (EVEROLIMUS) TABLET AFINITOR DISPERZ (EVEROLIMUS) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION] 64 Current NDC, Legacy NDC, 2 package rows 20250515_2150f73a-179b-4afc-b8ce-67c85cc72f04.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.
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 0078-0567-51 00078056751 28 BLISTER PACK in 1 CARTON (0078-0567-51) / 1 TABLET in 1 BLISTER PACK (0078-0567-61) 28 blister pack 2009-03-31 0000-00-00 No No Current 0078-0567-61 00078056761 1 in 1 BLISTER PACK Historical