Prescription drug · ANDA
Trientine hydrochloride NDC 72205-008
Trientine hydrochloride 250 mg/1 · Capsule · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-008-91 | 72205000891 | 1 BOTTLE in 1 CARTON (72205-008-91) / 100 CAPSULE in 1 BOTTLEMarketed from May 22, 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
- Novadoz Pharmaceuticals LLCNDC labeler code 72205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211134
- Marketing start
- Listing expires
- Other FDA classes
- Metal Chelating Activity (Mechanism)
- Identifiers
- Product ID 72205-008_da623cb5-cd76-4236-87ad-212e25349fcdSPL ID da623cb5-cd76-4236-87ad-212e25349fcdSPL set ID 6bc468ca-07ef-4965-b502-0330b76455a0RxCUI 313472UNII HC3NX54582UPC 0372205008915
- Pharmacologic class
- Metal 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
N472205000891followed by a unit qualifier and the quantityPackage 72205-0008-91. 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 capsules USP 250 mg is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride capsules USP 250 mg 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 capsules USP 250 mg and penicillamine cannot be considered interchangeable. Trientine hydrochloride capsules USP 250 mg should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects. Unlike penicillamine,…
Excerpt only. Read the full label for complete information.
About NDC 72205-008
- What is NDC 72205-008?
- 72205-008 is the product NDC for Trientine hydrochloride, Trientine hydrochloride 250 mg/1 capsule, listed with the FDA by Novadoz Pharmaceuticals LLC. 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?
- Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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 | 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 | Dr.Reddys Laboratories Inc | 43598-459 | 43598-0459-01 |