Prescription drug · ANDA
Nitisinone NDC 0254-3022
Nitisinone 10 mg/1 · Capsule · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0254-3022-02 | 00254302202 | 1 BOTTLE in 1 CARTON (0254-3022-02) / 60 CAPSULE in 1 BOTTLEMarketed from Oct 4, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nitisinone
- Generic name (nonproprietary)
- nitisinone
- Active ingredients
- Nitisinone — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Par Health USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211041
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2E1 Inducers (Mechanism)Hydroxyphenylpyruvate Dioxygenase Inhibitors (Mechanism)Organic Anion Transporter 1 Inhibitors (Mechanism)Organic Anion Transporter 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 0254-3022_403b3d85-e7be-4cc8-b286-bd0a099dae77SPL ID 403b3d85-e7be-4cc8-b286-bd0a099dae77SPL set ID 437868f5-1c9e-4b0f-8a03-77df8ac0900dRxCUI 351173, 351174, 351175UNII K5BN214699UPC 0302543022021, 0302543021024
- Pharmacologic class
- 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400254302202followed by a unit qualifier and the quantityPackage 00254-3022-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Nitisinone capsules are indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Nitisinone is a hydroxy-phenylpyruvate dioxygenase inhibitor indicated for the treatment of adult and pediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211041
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nitisinone | Nitisinone 2 mg/1 | CapsuleOral | Par Health USA, LLC | 0254-3020 |
| Nitisinone | Nitisinone 5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2235 |
| Nitisinone | Nitisinone 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2233 |
| Nitisinone | Nitisinone 5 mg/1 | CapsuleOral | Par Health USA, LLC | 0254-3021 |
| Nitisinone | Nitisinone 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-2234 |