Home NDC 63020-210 Fruzaqla
Product NDC 63020-210
11-digit product format 630200210
Labeler code 63020
Product ID 63020-210_8e86a087-ef8d-424c-8cfe-208bf8d4e122
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fruquintinib
Dosage form CAPSULE
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA217564
Marketing category NDA
Marketing start 2023-11-08
Substance FRUQUINTINIB
Active strength 1 mg/1
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 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 N217564-001 FRUZAQLA FRUQUINTINIB 1MG CAPSULE / ORAL RLD 2023-11-08 N217564-002 FRUZAQLA FRUQUINTINIB 5MG CAPSULE / ORAL RLD, RS 2023-11-08
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217564-001 8212033 2028-05-09 U-3753 2023-12-06 N217564-001 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 N217564-001 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 N217564-001 11046674 2035-09-07 U-3753 2023-12-06 N217564-002 8212033 2028-05-09 U-3753 2023-12-06 N217564-002 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 N217564-002 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 N217564-002 11046674 2035-09-07 U-3753 2023-12-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217564-001 NCE 2028-11-08 N217564-002 NCE 2028-11-08
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.
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 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217564-001 FRUZAQLA 1MG CAPSULE / ORAL RLD 2023-11-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217564-002 FRUZAQLA 5MG CAPSULE / ORAL RLD, RS 2023-11-08 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 160 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 N217564-001 8212033 2028-05-09 U-3753 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-001 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-001 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-001 11046674 2035-09-07 U-3753 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-002 8212033 2028-05-09 U-3753 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-002 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-002 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217564-002 11046674 2035-09-07 U-3753 2023-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217564-001 8212033 2028-05-09 U-3753 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-001 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-001 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-001 11046674 2035-09-07 U-3753 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-002 8212033 2028-05-09 U-3753 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-002 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-002 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217564-002 11046674 2035-09-07 U-3753 2023-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217564-001 8212033 2028-05-09 U-3753 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-001 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-001 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-001 11046674 2035-09-07 U-3753 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-002 8212033 2028-05-09 U-3753 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-002 7829574 2032-03-23 Drug substance, Drug product 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-002 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217564-002 11046674 2035-09-07 U-3753 2023-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-001 7829574 2028-05-09 Drug substance, Drug product 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-001 8212033 2028-05-09 U-3753 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-001 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-001 11046674 2035-09-07 U-3753 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-002 7829574 2028-05-09 Drug substance, Drug product 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-002 8212033 2028-05-09 U-3753 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-002 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217564-002 11046674 2035-09-07 U-3753 2023-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217564-001 7829574 2028-05-09 Drug substance, Drug product 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-001 8212033 2028-05-09 U-3753 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-001 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-001 11046674 2035-09-07 U-3753 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-002 7829574 2028-05-09 Drug substance, Drug product 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-002 8212033 2028-05-09 U-3753 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-002 10519142 2035-09-07 U-3753 Drug substance, Drug product 2023-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217564-002 11046674 2035-09-07 U-3753 2023-12-06 6a471c1ec25d…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fruzaqla
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FRUQUINTINIB 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 49DXG3M5ZW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2670184 Internal RxNorm lookup 2670190 Internal RxNorm lookup 2670196 Internal RxNorm lookup 2670198 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 63020-210-21 Fruzaqla 1 in 1 CARTON CAPSULE 1 6 63020-210-21 Fruzaqla 21 in 1 BOTTLE CAPSULE 21 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63020-210 FRUZAQLA (FRUQUINTINIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.] 5 Current NDC, 2 package rows 20250309_186d786e-dc8a-45f2-b5e1-01ac0201879f.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 Sample Exclude flag Status 63020-210-21 63020021021 1 BOTTLE in 1 CARTON (63020-210-21) / 21 CAPSULE in 1 BOTTLE 1 bottle 2023-11-08 No No Current