Prescription drug · NDA
Cuvrior (Trientine tetrahydrochloride) NDC 81802-001
Trientine tetrahydrochloride 300 mg/1 · Tablet, Film coated · Oral · Orphalan SA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81802-001-72 | 81802000172 | 9 CARTON in 1 CARTON (81802-001-72) / 1 BLISTER PACK in 1 CARTON (81802-001-08) / 8 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Sep 14, 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)
- Cuvrior
- Generic name (nonproprietary)
- trientine tetrahydrochloride
- Active ingredients
- Trientine tetrahydrochloride — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Orphalan SANDC labeler code 81802
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215760
- Marketing start
- Listing expires
- Other FDA classes
- Copper Chelating Activity (Mechanism)Metal Chelating Activity (Mechanism)
- Identifiers
- Product ID 81802-001_5a40d029-6e60-43ff-98b1-26702191766bSPL ID 5a40d029-6e60-43ff-98b1-26702191766bSPL set ID f73feeae-62ad-401e-b9f7-5cb269127750RxCUI 2611544, 2611550UNII 7360URE56Q
- Pharmacologic class
- Copper Chelator
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
N481802000172followed by a unit qualifier and the quantityPackage 81802-0001-72. 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)
CUVRIOR is indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. CUVRIOR is a copper chelator indicated for the treatment of adult patients with stable Wilson's disease who are de-coppered and tolerant to penicillamine. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 81802-001
- What is NDC 81802-001?
- 81802-001 is the product NDC for Cuvrior (trientine tetrahydrochloride), Trientine tetrahydrochloride 300 mg/1 tablet, film coated, listed with the FDA by Orphalan SA. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cuvrior (Trientine tetrahydrochloride).
- What is the active ingredient?
- Trientine tetrahydrochloride.
- Who is the labeler?
- Orphalan SA, NDC labeler code 81802. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cuvrior?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.