Home DailyMed fb0a8df2-67b8-4637-83af-ddee9dfb6b37 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 03:11:51 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022405-001 CAPRELSA VANDETANIB 100MG TABLET / ORAL RLD 2011-04-06 N022405-002 CAPRELSA VANDETANIB 300MG TABLET / ORAL RLD, RS 2011-04-06
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022405-001 8067427 2028-08-08 Drug product 2011-12-21 N022405-002 8067427 2028-08-08 Drug product
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 · 86 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 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 74a2ff9319b5…
Observed Orange Book patent history# Patent history page 1 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022405-002 8067427 2028-08-08 Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022405-002 8067427 2028-08-08 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022405-002 8067427 2028-08-08 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022405-002 8067427 2028-08-08 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022405-002 8067427 2028-08-08 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022405-002 8067427 2028-08-08 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022405-002 8067427 2028-08-08 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022405-002 8067427 2028-08-08 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022405-002 8067427 2028-08-08 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022405-002 8067427 2028-08-08 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022405-002 8067427 2028-08-08 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022405-002 8067427 2028-08-08 Drug product d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022405-002 8067427 2028-08-08 Drug product 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022405-002 8067427 2028-08-08 Drug product 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022405-002 8067427 2028-08-08 Drug product 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022405-002 8067427 2028-08-08 Drug product 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 8642608 2022-02-06 U-1490 2018-03-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 RE42353 2022-06-27 Drug substance, Drug product 2011-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 8642608 2022-02-06 U-1490 2018-03-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 RE42353 2022-06-27 Drug substance, Drug product 2011-06-03 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022405-002 8067427 2028-08-08 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022405-001 8642608 2022-02-06 U-1490 2018-03-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-001 RE42353 2022-06-27 Drug substance, Drug product 2011-06-03 5d02ea3f76ae…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.