Prescription drug · NDA
Orfadin (Nitisinone) NDC 66658-102
Nitisinone 2 mg/1 · Capsule · Oral · SWEDISH ORPHAN BIOVITRUM AB (PUBL)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66658-102-60 | 6665801026066658010260 | 1 BOTTLE, PLASTIC in 1 CARTON (66658-102-60) / 60 CAPSULE in 1 BOTTLE, PLASTICMarketed from Jul 1, 2016 |
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)
- Orfadin
- Generic name (nonproprietary)
- nitisinone
- Active ingredients
- Nitisinone — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- SWEDISH ORPHAN BIOVITRUM AB (PUBL)NDC labeler code 66658
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021232
- 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 66658-102_f9c6cef5-fb71-4cb0-9793-5c23ac04572eSPL ID f9c6cef5-fb71-4cb0-9793-5c23ac04572eSPL set ID 5d449b73-d503-4132-b978-d890491975dfRxCUI 351173, 351174, 351175, 352119, 352120, 352121, 1798999, 1799001UNII 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
N466658010260followed by a unit qualifier and the quantityPackage 66658-0102-60. 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)
ORFADIN ® 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. ORFADIN 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.
About NDC 66658-102
- What is NDC 66658-102?
- 66658-102 is the product NDC for Orfadin (nitisinone), Nitisinone 2 mg/1 capsule, listed with the FDA by SWEDISH ORPHAN BIOVITRUM AB (PUBL). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orfadin (Nitisinone).
- What is the active ingredient?
- Nitisinone.
- Who is the labeler?
- SWEDISH ORPHAN BIOVITRUM AB (PUBL), NDC labeler code 66658. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orfadin?
- 4 other product NDCs are listed under this name. See all Orfadin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orfadin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orfadinnitisinone | Nitisinone 5 mg/1 | CapsuleOral | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-105 | 66658-0105-60 |
| Orfadinnitisinone | Nitisinone 10 mg/1 | CapsuleOral | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-110 | 66658-0110-60 |
| Orfadinnitisinone | Nitisinone 20 mg/1 | CapsuleOral | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-120 | 66658-0120-60 |
| Orfadinnitisinone | Nitisinone 4 mg/mL | SuspensionOral | Swedish Orphan Biovitrum AB (publ) | 66658-204 | 66658-0204-90 |
Other NDCs under NDA 021232
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 |
|---|---|---|---|---|
| Orfadinnitisinone | Nitisinone 5 mg/1 | CapsuleOral | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-105 |
| Orfadinnitisinone | Nitisinone 10 mg/1 | CapsuleOral | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-110 |
| Orfadinnitisinone | Nitisinone 20 mg/1 | CapsuleOral | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | 66658-120 |