Search by Drug Name or NDC
NDC 63629-2235-01 Nitisinone 5 mg/1 Details
Nitisinone 5 mg/1
Nitisinone is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is NITISINONE.
Product Information
| NDC | 63629-2235 |
|---|---|
| Product ID | 63629-2235_8daf42bc-595c-48fd-aa3b-cbabbadde0c8 |
| Associated GPIs | 30904045000120 |
| GCN Sequence Number | 049854 |
| GCN Sequence Number Description | nitisinone CAPSULE 5 MG ORAL |
| HIC3 | D7D |
| HIC3 Description | DRUGS TO TREAT HEREDITARY TYROSINEMIA |
| GCN | 15663 |
| HICL Sequence Number | 023253 |
| HICL Sequence Number Description | NITISINONE |
| Brand/Generic | Generic |
| Proprietary Name | Nitisinone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Nitisinone |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | NITISINONE |
| Labeler Name | Bryant Ranch Prepack |
| Pharmaceutical Class | 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 I |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA211041 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 63629-2235-01 (63629223501)
| NDC Package Code | 63629-2235-1 |
|---|---|
| Billing NDC | 63629223501 |
| Package | 1 BOTTLE in 1 CARTON (63629-2235-1) / 60 CAPSULE in 1 BOTTLE |
| Marketing Start Date | 2021-03-22 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |