Nitisinone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Par Pharmaceutical, Inc.. The primary component is Nitisinone.
| Product ID | 0254-3021_75548bb0-fbf1-4ac5-86af-cd6dc30de589 |
| NDC | 0254-3021 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Nitisinone |
| Generic Name | Nitisinone |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-10-04 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211041 |
| Labeler Name | Par Pharmaceutical, Inc. |
| Substance Name | NITISINONE |
| Active Ingredient Strength | 5 mg/1 |
| Pharm Classes | 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC],Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-10-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA211041 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2018-10-01 |
| Marketing End Date | 2019-10-29 |
| Marketing Category | ANDA |
| Application Number | ANDA211041 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-10-04 |
| Ingredient | Strength |
|---|---|
| NITISINONE | 5 mg/1 |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0254-3020 | Nitisinone | Nitisinone |
| 0254-3021 | Nitisinone | Nitisinone |
| 0254-3022 | Nitisinone | Nitisinone |
| 63629-2233 | Nitisinone | Nitisinone |
| 63629-2234 | Nitisinone | Nitisinone |
| 63629-2235 | Nitisinone | Nitisinone |
| 70505-202 | Nitisinone | Nitisinone |
| 70505-205 | Nitisinone | Nitisinone |
| 70505-210 | Nitisinone | Nitisinone |
| 70954-010 | Nitisinone | Nitisinone |
| 70954-008 | Nitisinone | Nitisinone |
| 70954-009 | Nitisinone | Nitisinone |
| 70709-000 | NITYR | Nitisinone |
| 70709-002 | NITYR | Nitisinone |
| 70709-005 | NITYR | Nitisinone |
| 66658-102 | Orfadin | Nitisinone |
| 66658-105 | Orfadin | Nitisinone |
| 66658-110 | Orfadin | Nitisinone |
| 66658-120 | Orfadin | Nitisinone |
| 66658-204 | ORFADIN | nitisinone |