Nitisinone
- Product NDC
- 70954-008
- 11-digit product format
- 709540008
- Labeler code
- 70954
- Product ID
- 70954-008_cf72aab3-f579-4537-9ca1-a02adbd86037
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nitisinone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA211041
- Marketing category
- ANDA
- Marketing start
- 2019-08-26
- Marketing end
- 0000-00-00
- Substance
- NITISINONE
- Active strength
- 2 mg/1
- Pharmacologic classes
- 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A211041-001 | AB |
| A211041-002 | AB |
| A211041-003 | AB |
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 | 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 | A211041-001 | NITISINONE | 2MG | CAPSULE / ORAL | AB | 2019-08-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211041-002 | NITISINONE | 5MG | CAPSULE / ORAL | AB | 2019-08-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211041-003 | NITISINONE | 10MG | CAPSULE / ORAL | AB | 2019-08-26 | caaa826d4ba7… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211041-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211041-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211041-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211041-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211041-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211041-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211041-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211041-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211041-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211041-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211041-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211041-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211041-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211041-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211041-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211041-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211041-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211041-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211041-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211041-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211041-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211041-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211041-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211041-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211041-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211041-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211041-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211041-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211041-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211041-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211041-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211041-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211041-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211041-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211041-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211041-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211041-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211041-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211041-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211041-001 | AB | 1 | 1e350fbaab3a… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nitisinone | NITISINONE | Par Health USA, LLC | 437868f5-1c9e-4b0f-8a03-77df8ac0900d | 2026-08-06 | Warnings, Adverse reactions | 211041 ANDA211041 |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | c1b3adc8-02fa-4e22-8c05-8f32b586e53f | 2024-01-10 | Warnings, Adverse reactions | 211041 ANDA211041 |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | 8cec0318-9f55-4340-b14b-588635619251 | 2024-01-10 | Warnings, Adverse reactions | 211041 ANDA211041 |
| Nitisinone | NITISINONE | Bryant Ranch Prepack | b7c38003-6899-4508-a69a-aef1231de22c | 2024-01-10 | Warnings, Adverse reactions | 211041 ANDA211041 |