Prescription drug · NDA
Nityr (Nitisinone) NDC 70709-000
Nitisinone 10 mg/1 · Tablet · Oral · Cycle Pharmaceuticals Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70709-000-60 | 7070900006070709000060 | 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) / 60 TABLET in 1 BOTTLE, PLASTICMarketed from Jul 26, 2017 |
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)
- Nityr
- Generic name (nonproprietary)
- nitisinone
- Active ingredients
- Nitisinone — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cycle Pharmaceuticals Ltd.NDC labeler code 70709
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209449
- 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 70709-000_9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92SPL ID 9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92SPL set ID 00fd1905-27e4-420e-8dc5-a69e4ddc1526RxCUI 1941464, 1941470, 1941471, 1941473, 1941474, 1941476UNII K5BN214699UPC 0370709000602, 0370709002606, 0370709005607
- 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
N470709000060followed by a unit qualifier and the quantityPackage 70709-0000-60. 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)
NITYR ® is 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. NITYR is a hydroxyphenyl-pyruvate 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.
About NDC 70709-000
- What is NDC 70709-000?
- 70709-000 is the product NDC for Nityr (nitisinone), Nitisinone 10 mg/1 tablet, listed with the FDA by Cycle Pharmaceuticals Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nityr (Nitisinone).
- What is the active ingredient?
- Nitisinone.
- Who is the labeler?
- Cycle Pharmaceuticals Ltd., NDC labeler code 70709. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nityr?
- 2 other product NDCs are listed under this name. See all Nityr NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nityr products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nityrnitisinone | Nitisinone 2 mg/1 | TabletOral | Cycle Pharmaceuticals Ltd. | 70709-002 | 70709-0002-60 |
| Nityrnitisinone | Nitisinone 5 mg/1 | TabletOral | Cycle Pharmaceuticals Ltd. | 70709-005 | 70709-0005-60 |
Other NDCs under NDA 209449
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 |
|---|---|---|---|---|
| Harlikunitisinone | Nitisinone 2 mg/1 | TabletOral | Cycle Pharmaceuticals Ltd. | 70709-112 |
| Nityrnitisinone | Nitisinone 2 mg/1 | TabletOral | Cycle Pharmaceuticals Ltd. | 70709-002 |
| Nityrnitisinone | Nitisinone 5 mg/1 | TabletOral | Cycle Pharmaceuticals Ltd. | 70709-005 |