What is NDC 43598-459?

43598-459 is the product NDC for Trientine Hydrochloride, Trientine hydrochloride 250 mg/1 capsule, listed with the FDA by Dr.Reddys Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr.Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Trientine Hydrochloride?

6 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Trientine Hydrochloride NDC 43598-459

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-459Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0459Add 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
43598-459-01	4359804590143598045901	100 CAPSULE in 1 BOTTLE (43598-459-01)Marketed from Jul 3, 2019

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: Dr.Reddys Laboratories IncNDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211076
Marketing start: Jul 3, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Copper Chelating Activity (Mechanism)Metal Chelating Activity (Mechanism)
Identifiers: Product ID 43598-459_bdfcecdc-5523-2091-0405-62d51c91e287SPL ID bdfcecdc-5523-2091-0405-62d51c91e287SPL set ID fff41159-af99-94bf-4327-8a6a7ee77b36RxCUI 313472UNII HC3NX54582
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

N443598045901 followed by a unit qualifier and the quantity

Package 43598-0459-01. 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 Dec 19, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride 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 and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride capsules are not recommended in cyst…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-459

What is NDC 43598-459?: 43598-459 is the product NDC for Trientine Hydrochloride, Trientine hydrochloride 250 mg/1 capsule, listed with the FDA by Dr.Reddys Laboratories Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Trientine Hydrochloride.
What is the active ingredient?: Trientine hydrochloride.
Who is the labeler?: Dr.Reddys Laboratories Inc, NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Trientine Hydrochloride?: 6 other product NDCs are listed under this name. See all Trientine Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Trientine Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Trientine Hydrochloride	Trientine hydrochloride 500 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-812	16571-0812-05
Trientine Hydrochloride	Trientine hydrochloride 250 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-683	31722-0683-01
Trientine Hydrochloride	Trientine hydrochloride 250 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-810	16571-0810-01
Trientine Hydrochloride	Trientine hydrochloride 250 mg/1	CapsuleOral	Navinta LLC	68475-200	68475-0200-01
Trientine Hydrochloride	Trientine hydrochloride 250 mg/1	CapsuleOral	Par Health USA, LLC	49884-060	49884-0060-01
Trientine hydrochloride	Trientine hydrochloride 250 mg/1	CapsuleOral	Novadoz Pharmaceuticals LLC	72205-008	72205-0008-91