Prescription drug · ANDA
Tetrabenazine NDC 47335-179
Tetrabenazine 25 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-179-23 | 4733501792347335017923 | 112 TABLET in 1 BOTTLE (47335-179-23)Marketed from Aug 17, 2015 |
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
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206129
- Marketing start
- Listing expires
- Other FDA classes
- Vesicular Monoamine Transporter 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-179_86ebe1dd-8c77-4615-8a4c-1e8ec4dc0098SPL ID 86ebe1dd-8c77-4615-8a4c-1e8ec4dc0098SPL set ID b7d93006-7f06-4da4-985e-6b948c2468e8RxCUI 199592, 805464UNII Z9O08YRN8OUPC 0347335179231
- 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
N447335017923followed by a unit qualifier and the quantityPackage 47335-0179-23. 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 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 47335-179
- What is NDC 47335-179?
- 47335-179 is the product NDC for Tetrabenazine, Tetrabenazine 25 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tetrabenazine.
- What is the active ingredient?
- Tetrabenazine.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tetrabenazine?
- 21 other product NDCs are listed under this name. See all Tetrabenazine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tetrabenazine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-938 | 23155-0938-63 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-939 | 23155-0939-63 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Precision Dose Inc. | 68094-805 | 68094-0805-10 |
| Tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Precision Dose Inc. | 68094-905 | 68094-0905-10 |
| Tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-176 | 27241-0176-13 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-177 | 27241-0177-13 |
| Tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Apotex Corp. | 60505-3882 | 60505-3882-07 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Apotex Corp. | 60505-3883 | 60505-3883-07 |
| Tetrabenazine | Tetrabenazine 12.5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-480 | 51407-0480-12 |
| Tetrabenazine | Tetrabenazine 25 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-481 | 51407-0481-12 |
Other NDCs under ANDA 206129
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 | Sun Pharmaceutical Industries, Inc. | 47335-277 |