Prescription drug · ANDA
Trientine Hydrochloride NDC 16571-810
Trientine hydrochloride 250 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-810-01 | 16571081001 | 100 CAPSULE in 1 BOTTLE (16571-810-01)Marketed from Mar 30, 2021 |
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
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212238
- Marketing start
- Listing expires
- Other FDA classes
- Copper Chelating Activity (Mechanism)Metal Chelating Activity (Mechanism)
- Identifiers
- Product ID 16571-810_96619f61-e1f2-4ed3-9a81-c05077c8cbcbSPL ID 96619f61-e1f2-4ed3-9a81-c05077c8cbcbSPL set ID f33c1322-f7c0-4684-afc8-8caa3f4023dcRxCUI 313472, 2619912UNII 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
N416571081001followed by a unit qualifier and the quantityPackage 16571-0810-01. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Trientine hydrochloride is 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 should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthriti…
Excerpt only. Read the full label for complete information.
About NDC 16571-810
- What is NDC 16571-810?
- 16571-810 is the product NDC for Trientine Hydrochloride, Trientine hydrochloride 250 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, 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?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. 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.
Related NDCs: other Trientine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 | 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 | Dr.Reddys Laboratories Inc | 43598-459 | 43598-0459-01 |
| Trientine hydrochloride | Trientine hydrochloride 250 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-008 | 72205-0008-91 |
Other NDCs under ANDA 212238
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 |
|---|---|---|---|---|
| Trientine Hydrochloride | Trientine hydrochloride 500 mg/1 | CapsuleOral | Rising Pharma Holdings, Inc. | 16571-812 |