Prescription drug · ANDA
Trientine Hydrochloride NDC 31722-683
Trientine hydrochloride 250 mg/1 · Capsule · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-683-01 | 31722068301 | 1 BOTTLE in 1 CARTON (31722-683-01) / 100 CAPSULE in 1 BOTTLEMarketed from Jun 23, 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)
- Trientine Hydrochloride
- Generic name (nonproprietary)
- trientine hydrochloride
- Active ingredients
- Trientine hydrochloride — 250 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216356
- Marketing start
- Listing expires
- Other FDA classes
- Metal Chelating Activity (Mechanism)
- Identifiers
- Product ID 31722-683_e53ee9ec-7121-2b81-e053-2a95a90afe9fSPL ID e53ee9ec-7121-2b81-e053-2a95a90afe9fSPL set ID 5240e3de-54b6-4f22-9142-776f0e9ea1d9RxCUI 313472UNII HC3NX54582UPC 0331722683012
- 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
N431722068301followed by a unit qualifier and the quantityPackage 31722-0683-01. 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 & 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 capsules are 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 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 re…
Excerpt only. Read the full label for complete information.
About NDC 31722-683
- What is NDC 31722-683?
- 31722-683 is the product NDC for Trientine Hydrochloride, Trientine hydrochloride 250 mg/1 capsule, listed with the FDA by Camber Pharmaceuticals, 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?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 | 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 |
| Trientine hydrochloride | Trientine hydrochloride 250 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-008 | 72205-0008-91 |