NDC 70954-008
Nitisinone
Nitisinone
Nitisinone is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novitium Pharma Llc. The primary component is Nitisinone.
| Product ID | 70954-008_76da5c07-0bd8-4f69-8e71-9d72ce2dc92f |
| NDC | 70954-008 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Nitisinone |
| Generic Name | Nitisinone |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-10-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA211041 |
| Labeler Name | Novitium Pharma LLC |
| Substance Name | NITISINONE |
| Active Ingredient Strength | 2 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 |