Prescription drug · ANDA
Tetrabenazine NDC 51407-481
Tetrabenazine 25 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-481-12 | 51407048112 | 112 TABLET in 1 BOTTLE (51407-481-12)Marketed from Jul 26, 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)
- Tetrabenazine
- Generic name (nonproprietary)
- tetrabenazine
- Active ingredients
- Tetrabenazine — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206093
- Marketing start
- Listing expires
- Other FDA classes
- Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 51407-481_410f7183-66d2-9ae2-e063-6394a90ac256SPL ID 410f7183-66d2-9ae2-e063-6394a90ac256SPL set ID cbfb791e-26ac-9fb5-e053-2995a90ac7e5RxCUI 199592, 805464UNII 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
N451407048112followed by a unit qualifier and the quantityPackage 51407-0481-12. 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 ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206093
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 | Apotex Corp. | 60505-3882 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Apotex Corp. | 60505-3883 |
| Tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-480 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.