Home NDC 70709-000 NITYR
Product NDC 70709-000
11-digit product format 707090000
Labeler code 70709
Product ID 70709-000_3cb64253-f5db-48a4-a7b4-a5b8526dfe23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitisinone
Dosage form TABLET
Route ORAL
Labeler Cycle Pharmaceuticals Ltd.
Application NDA209449
Marketing category NDA
Marketing start 2017-07-26
Substance NITISINONE
Active strength 10 mg/1
Pharmacologic classes 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2E1 Inducers [MoA], Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA], Organic Anion Transporter 1 Inhibitors [MoA], Organic Anion Transporter 3 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 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209449-001 NITYR NITISINONE 2MG TABLET / ORAL RLD 2017-07-26 N209449-002 NITYR NITISINONE 5MG TABLET / ORAL RLD 2017-07-26 N209449-003 NITYR NITISINONE 10MG TABLET / ORAL RLD, RS 2017-07-26 N209449-004 HARLIKU NITISINONE 2MG TABLET / ORAL RLD, RS 2025-06-10
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209449-004 ODE-529 2032-06-10
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 4 · 139 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 2026-10-15 13:18:30 2026-09 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 d8e5a09893c0…
Observed Orange Book patent history# Patent history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 79d66fd596c7…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-10-15 13:18:30 2026-09 N209449-004 ODE-529 2032-06-10 c2088c7a36db…2026-09-14 22:38:34 2026-08 N209449-004 ODE-529 2032-06-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N209449-004 ODE-529 2032-06-10 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209449-004 ODE-529 2032-06-10 a50c72e98297…
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 NITYR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITISINONE 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70709-000-60 NITYR 60 in 1 BOTTLE, PLASTIC TABLET 60 13 70709-000-60 NITYR 1 in 1 CARTON TABLET 1 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70709-000 NITYR (NITISINONE) TABLET [CYCLE PHARMACEUTICALS LTD.] 12 Current NDC, Legacy NDC, 2 package rows 20240601_00fd1905-27e4-420e-8dc5-a69e4ddc1526.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HARLIKU NITISINONE Cycle Pharmaceuticals Ltd. 7cf67e24-d46b-4376-bbd0-0b973c406d0d 2025-06-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 209449 application number: NDA209449
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 70709-000-60 70709000060 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) / 60 TABLET in 1 BOTTLE, PLASTIC 2017-07-26 0000-00-00 No No Current