Prescription drug · ANDA
Tetrabenazine NDC 23155-938
Tetrabenazine 12.5 mg/1 · Tablet · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-938-63 | 23155093863 | 112 TABLET in 1 BOTTLE (23155-938-63)Marketed from Sep 1, 2025 |
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)
- Tetrabenazine
- Generic name (nonproprietary)
- tetrabenazine
- Active ingredients
- Tetrabenazine — 12.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213316
- Marketing start
- Listing expires
- Other FDA classes
- Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 23155-938_b4b833f2-4424-46a8-b5df-ad62c36c7d75SPL ID b4b833f2-4424-46a8-b5df-ad62c36c7d75SPL set ID 5042f30c-c922-4835-bf6d-40905f2dc76cRxCUI 199592, 805464UNII Z9O08YRN8OUPC 0323155939637, 0323155938630
- 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
N423155093863followed by a unit qualifier and the quantityPackage 23155-0938-63. 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)
Tetrabenazine tablets are indicated for the treatment of chorea associated with Huntington’s disease. Tetrabenazine tablets are a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213316
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 25 mg/1 | TabletOral | Slate Run Pharmaceuticals, LLC | 70436-102 |
| tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Slate Run Pharmaceuticals, LLC | 70436-101 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-939 |