Home NDC 42747-602 NOURIANZ
Product NDC 42747-602
11-digit product format 427470602
Labeler code 42747
Product ID 42747-602_607b4223-661d-45e0-8209-99c5ba62d5c0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name istradefylline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Kyowa Kirin, Inc.
Application NDA022075
Marketing category NDA
Marketing start 2019-08-27
Substance ISTRADEFYLLINE
Active strength 20 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 N022075-001 NOURIANZ ISTRADEFYLLINE 20MG TABLET / ORAL RLD 2019-08-27 N022075-002 NOURIANZ ISTRADEFYLLINE 40MG TABLET / ORAL RLD, RS 2019-08-27
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022075-001 8318201 2027-09-05 Drug product 2019-09-25 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25
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 2026-08-18 06:07:40 2026-07 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022075-001 NOURIANZ 20MG TABLET / ORAL RLD 2019-08-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022075-002 NOURIANZ 40MG TABLET / ORAL RLD, RS 2019-08-27 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 7 · 270 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 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-001 7541363 2024-11-13 Drug substance, Drug product 2019-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-002 7541363 2024-11-13 Drug substance, Drug product 2019-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-001 7541363 2024-11-13 Drug substance, Drug product 2019-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-002 7541363 2024-11-13 Drug substance, Drug product 2019-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-002 8318201 2027-09-05 Drug product 2019-09-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022075-002 7727993 2028-01-28 U-2623 Drug product 2019-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022075-001 7541363 2024-11-13 Drug substance, Drug product 2019-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022075-001 8318201 2027-09-05 Drug product 2019-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022075-001 7727993 2028-01-28 U-2623 Drug product 2019-09-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022075-002 7541363 2024-11-13 Drug substance, Drug product 2019-09-25 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NOURIANZ
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ISTRADEFYLLINE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2GZ0LIK7T4 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2199020 Internal RxNorm lookup 2199026 Internal RxNorm lookup 2199028 Internal RxNorm lookup 2199030 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 42747-602-07 NOURIANZ 1 in 1 BOX TABLET, FILM COATED 1 6 42747-602-07 NOURIANZ 7 in 1 BLISTER PACK TABLET, FILM COATED 7 6 42747-602-90 NOURIANZ 90 in 1 BOTTLE TABLET, FILM COATED 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42747-602 NOURIANZ (ISTRADEFYLLINE) TABLET, FILM COATED [KYOWA KIRIN, INC.] 6 Current NDC, Legacy NDC, 3 package rows 20250523_a7d008cb-b273-4049-a5d2-9c6902910d58.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 42747-602-07 42747060207 1 BLISTER PACK in 1 BOX (42747-602-07) / 7 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2019-08-27 0000-00-00 Yes No Current 42747-602-90 42747060290 90 TABLET, FILM COATED in 1 BOTTLE (42747-602-90) 2019-08-27 0000-00-00 No No Current