Home NDC 58468-7820 CAPRELSA
Product NDC 58468-7820
11-digit product format 584687820
Labeler code 58468
Product ID 58468-7820_abb9eb38-c6a9-49e9-8e90-852f95773feb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vandetanib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genzyme Corporation
Application NDA022405
Marketing category NDA
Marketing start 2011-07-25
Substance VANDETANIB
Active strength 100 mg/1
Pharmacologic classes Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA], Protein 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 42 .
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 · 84 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 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…2022-03-09 01:35 UTC 2022-03 N022405-001 CAPRELSA 100MG TABLET / ORAL RLD 2011-04-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022405-002 CAPRELSA 300MG TABLET / ORAL RLD, RS 2011-04-06 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 5 · 174 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 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…2022-04-08 23:34 UTC 2022-04 N022405-001 8067427 2028-08-08 Drug product 2011-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022405-002 8642608 2022-02-06 U-1490 2018-03-05 5d02ea3f76ae…
Additional Listing Data#
Finished product Yes
Brand name base CAPRELSA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VANDETANIB 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YO460OQ37K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1098416 Internal RxNorm lookup 1098418 Internal RxNorm lookup 1114074 Internal RxNorm lookup 1114096 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 58468-7820-3 CAPRELSA 1 in 1 CARTON TABLET, FILM COATED 1 14 58468-7820-3 CAPRELSA 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58468-7820 CAPRELSA (VANDETANIB) TABLET, FILM COATED [GENZYME CORPORATION] 11 Current NDC, Legacy NDC, 2 package rows 20250523_e5721cb8-4185-47b9-bbb3-1c587e558a03.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 Marketing start Marketing end Sample Exclude flag Status 58468-7820-3 58468782003 1 BOTTLE, PLASTIC in 1 CARTON (58468-7820-3) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2011-07-25 0000-00-00 No No Current