Trientine Hydrochloride NDC 68475-200

NDC codes

FDA NDC Directory

Product NDC (as listed)68475-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68475-0200Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68475-200-01	68475020001	1 BOTTLE in 1 CARTON (68475-200-01) / 100 CAPSULE in 1 BOTTLEMarketed from Dec 5, 2020

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): Trientine Hydrochloride
Generic name (nonproprietary): trientine hydrochloride
Active ingredients: Trientine hydrochloride — 250 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Navinta LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211251
Marketing start: Dec 5, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Copper Chelating Activity (Mechanism)Metal Chelating Activity (Mechanism)
Identifiers: Product ID 68475-200_57f9ea43-344a-4050-ab62-4087d5961767SPL ID 57f9ea43-344a-4050-ab62-4087d5961767SPL set ID 4c9233bd-be3d-46f0-8fa9-a17e61b1b9a8RxCUI 313472UNII HC3NX54582UPC 0368475200012
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

N468475020001 followed by a unit qualifier and the quantity

Package 68475-0200-01. 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 Feb 25, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Trientine Hydrochloride Capsule is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with Trientine Hydrochloride Capsule is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine Hydrochloride Capsule and penicillamine cannot be considered interchangeable. Trientine hydrochloride Capsule should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, Trientine Hydrochloride Capsule is not recommen…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)