Prescription drug · NDA
Xenazine (Tetrabenazine) NDC 67386-422
Tetrabenazine 25 mg/1 · Tablet · Oral · Lundbeck Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67386-422-01 | 6738604220167386042201 | 112 TABLET in 1 BOTTLE (67386-422-01)Marketed from Nov 24, 2008 |
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)
- Xenazine
- Generic name (nonproprietary)
- tetrabenazine
- Active ingredients
- Tetrabenazine — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lundbeck Pharmaceuticals LLCNDC labeler code 67386
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021894
- Marketing start
- Listing expires
- Other FDA classes
- Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 67386-422_6f524695-2fc1-4c54-9212-69cff22cdfa7SPL ID 6f524695-2fc1-4c54-9212-69cff22cdfa7SPL set ID ac768bab-8afa-4446-bc7f-caeeffec0cdaRxCUI 199592, 805462, 805464, 805466UNII Z9O08YRN8O
- Pharmacologic class
- Vesicular Monoamine Transporter 2 Inhibitor
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
N467386042201followed by a unit qualifier and the quantityPackage 67386-0422-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 67386-422
- What is NDC 67386-422?
- 67386-422 is the product NDC for Xenazine (tetrabenazine), Tetrabenazine 25 mg/1 tablet, listed with the FDA by Lundbeck Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xenazine (Tetrabenazine).
- What is the active ingredient?
- Tetrabenazine.
- Who is the labeler?
- Lundbeck Pharmaceuticals LLC, NDC labeler code 67386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xenazine?
- 1 other product NDC are listed under this name. See all Xenazine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xenazine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xenazinetetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Lundbeck Pharmaceuticals LLC | 67386-421 | 67386-0421-01 |
Other NDCs under NDA 021894
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 |
|---|---|---|---|---|
| tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-421 |
| tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Oceanside Pharmaceuticals | 68682-422 |
| Xenazinetetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Lundbeck Pharmaceuticals LLC | 67386-421 |