Home NDC 0254-3020 Nitisinone
Product NDC 0254-3020
11-digit product format 002543020
Labeler code 0254
Product ID 0254-3020_8d22274c-76b2-4da0-85e0-c0fc61c7db0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitisinone
Dosage form CAPSULE
Route ORAL
Labeler Endo USA, Inc.
Application ANDA211041
Marketing category ANDA
Marketing start 2019-10-04
Substance NITISINONE
Active strength 2 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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211041-001 NITISINONE NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 A211041-002 NITISINONE NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 A211041-003 NITISINONE NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 120 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 2026-02-19 14:30 UTC 2026-02 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211041-002 NITISINONE 5MG CAPSULE / ORAL AB 2019-08-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211041-003 NITISINONE 10MG CAPSULE / ORAL AB 2019-08-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211041-001 NITISINONE 2MG CAPSULE / ORAL AB 2019-08-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 120 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Nitisinone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITISINONE 2 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 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 0254-3020-02 Nitisinone 1 in 1 CARTON CAPSULE 1 7 0254-3020-02 Nitisinone 60 in 1 BOTTLE CAPSULE 60 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0254-3020 NITISINONE CAPSULE [ENDO USA, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250406_437868f5-1c9e-4b0f-8a03-77df8ac0900d.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 · 4 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 0254-3020-02 00254302002 1 BOTTLE in 1 CARTON (0254-3020-02) / 60 CAPSULE in 1 BOTTLE 1 bottle 2019-10-04 0000-00-00 No No Current