Home NDC 63539-026 INLYTA
Product NDC 63539-026
11-digit product format 635390026
Labeler code 63539
Product ID 63539-026_0c63e82e-8c0d-4177-8748-20c2ece2b5e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name axitinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler U.S. Pharmaceuticals
Application NDA202324
Marketing category NDA
Marketing start 2012-01-27
Substance AXITINIB
Active strength 1 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Receptor Tyrosine Kinase 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 1 .
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 N202324-001 INLYTA AXITINIB 1MG TABLET / ORAL RLD 2012-01-27 N202324-002 INLYTA AXITINIB 5MG TABLET / ORAL RLD, RS 2012-01-27
Orange Book patents# Current patent rows page 1 of 1 · 18 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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N202324-001 INLYTA 1MG TABLET / ORAL AB RLD 2012-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 INLYTA 5MG TABLET / ORAL AB RLD, RS 2012-01-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 INLYTA 1MG TABLET / ORAL AB RLD 2012-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 INLYTA 5MG TABLET / ORAL AB RLD, RS 2012-01-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202324-001 INLYTA 1MG TABLET / ORAL RLD 2012-01-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N202324-002 INLYTA 5MG TABLET / ORAL RLD, RS 2012-01-27 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202324-001 AB 1 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 AB 1 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 AB 1 31067a03dcf5…
Observed Orange Book patent history# Patent history page 1 of 11 · 414 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202324-001 8791140 2030-12-14 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-001 8791140*PED 2031-06-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-001 10570202 2035-02-03 U-2844 2020-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-001 10570202*PED 2035-08-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-001 10869924 2037-01-12 U-3044 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-001 10869924*PED 2037-07-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 8791140 2030-12-14 Drug substance 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 8791140*PED 2031-06-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 10570202 2035-02-03 U-2844 2020-06-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 10570202*PED 2035-08-03 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 10869924 2037-01-12 U-3044 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202324-002 10869924*PED 2037-07-12 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 6534524 2025-04-29 Drug substance, Drug product 2012-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 6534524*PED 2025-10-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 8791140 2030-12-14 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 8791140*PED 2031-06-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 10570202 2035-02-03 U-2844 2020-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 10570202*PED 2035-08-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 10869924 2037-01-12 U-3044 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-001 10869924*PED 2037-07-12 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 6534524 2025-04-29 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 6534524*PED 2025-10-29 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 8791140 2030-12-14 Drug substance 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 8791140*PED 2031-06-14 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 10570202 2035-02-03 U-2844 2020-06-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 10570202*PED 2035-08-03 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 10869924 2037-01-12 U-3044 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202324-002 10869924*PED 2037-07-12 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202324-001 6534524 2025-04-29 Drug substance, Drug product 2012-02-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 6534524*PED 2025-10-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 8791140 2030-12-14 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 8791140*PED 2031-06-14 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 10570202 2035-02-03 U-2844 2020-06-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 10570202*PED 2035-08-03 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 10869924 2037-01-12 U-3044 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-001 10869924*PED 2037-07-12 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-002 6534524 2025-04-29 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-002 6534524*PED 2025-10-29 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-002 8791140 2030-12-14 Drug substance 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202324-002 8791140*PED 2031-06-14 Pediatric extension 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base INLYTA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AXITINIB 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C9LVQ0YUXG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1243004 Internal RxNorm lookup 1243010 Internal RxNorm lookup 1243012 Internal RxNorm lookup 1243014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63539-026-01 INLYTA 90 in 1 BOTTLE TABLET, FILM COATED 90 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AXITINIB ACTIVE INGREDIENT C9LVQ0YUXG INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 AXITINIB ACTIVE MOIETY C9LVQ0YUXG INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 HYPROMELLOSE 2910 (15000 MPA.S) INACTIVE INGREDIENT 288VBX44JC INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63539-026 INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] 11 Current NDC, Legacy NDC, 1 package rows 20250101_8a903e31-936e-4ed7-8a59-59f32374f338.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 · 2 matching rows.
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 63539-026-01 63539002601 90 TABLET, FILM COATED in 1 BOTTLE (63539-026-01) 2012-01-27 0000-00-00 Yes No Current