Home NDC 71863-121 Nitisinone
Product NDC 71863-121
11-digit product format 718630121
Labeler code 71863
Product ID 71863-121_42c7c79b-1aa1-12bc-e063-6394a90a5ff8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitisinone
Dosage form CAPSULE
Route ORAL
Labeler Eton Pharmaceuticals, Inc.
Application ANDA216201
Marketing category ANDA
Marketing start 2024-01-15
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 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216201-001 NITISINONE NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 A216201-002 NITISINONE NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 A216201-003 NITISINONE NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 A216201-004 NITISINONE NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 92 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 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-001 NITISINONE 2MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-002 NITISINONE 5MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-003 NITISINONE 10MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216201-004 NITISINONE 20MG CAPSULE / ORAL AB 2023-05-25 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 92 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nitisinone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITISINONE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K5BN214699 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351173 Internal RxNorm lookup 351174 Internal RxNorm lookup 351175 Internal RxNorm lookup 1798999 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 71863-121-60 Nitisinone 60 in 1 BOTTLE CAPSULE 60 5 71863-121-60 Nitisinone 1 in 1 CARTON CAPSULE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71863-121 NITISINONE CAPSULE [ETON PHARMACEUTICALS, INC.] 4 Current NDC, 2 package rows 20241207_dc5e4875-fcd7-408c-88c9-4a715f4384b6.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 71863-121-60 71863012160 1 BOTTLE in 1 CARTON (71863-121-60) / 60 CAPSULE in 1 BOTTLE 1 bottle 2024-01-15 No No Current