Prescription drug · ANDA
Nitisinone NDC 70505-210
Nitisinone 10 mg/1 · Capsule · Oral · Analog Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70505-210-60 | 70505021060 | 1 BOTTLE, PLASTIC in 1 CARTON (70505-210-60) / 60 CAPSULE in 1 BOTTLE, PLASTICMarketed from Jun 15, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- Analog Pharma
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212390
- 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 70505-210_f74e0d5c-aaae-4751-a24d-4d141dfcae61SPL ID f74e0d5c-aaae-4751-a24d-4d141dfcae61SPL set ID 645c8387-30d5-4a86-a5d8-2f6b5df6d5f0RxCUI 351173, 351174, 351175, 1798999UNII K5BN214699
- 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
N470505021060followed by a unit qualifier and the quantityPackage 70505-0210-60. 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 capsules are 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 212390
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 | Analog Pharma | 70505-202 |
| Nitisinone | Nitisinone 5 mg/1 | CapsuleOral | Analog Pharma | 70505-205 |
| Nitisinone | Nitisinone 20 mg/1 | CapsuleOral | Analog Pharma | 70505-220 |