Prescription drug · ANDA
vilazodone hydrochloride NDC 82804-128
Vilazodone hydrochloride 40 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-128-30 | 82804012830 | 30 TABLET in 1 BOTTLE (82804-128-30)Marketed from Jul 19, 2024 |
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)
- vilazodone hydrochloride
- Generic name (nonproprietary)
- vilazodone hydrochloride
- Active ingredients
- Vilazodone hydrochloride — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208228
- Marketing start
- Listing expires
- Identifiers
- Product ID 82804-128_f68720fd-9122-4922-b472-733da8bd0a00SPL ID f68720fd-9122-4922-b472-733da8bd0a00SPL set ID f68720fd-9122-4922-b472-733da8bd0a00RxCUI 1086784UNII U8HTX2GK8JUPC 0382804128303
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
N482804012830followed by a unit qualifier and the quantityPackage 82804-0128-30. 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)
Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208228
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 |
|---|---|---|---|---|
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8734 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8735 |
| vilazodone hydrochloride | Vilazodone hydrochloride 10 mg/1 | TabletOral | Northstar Rx LLC | 72603-813 |
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Northstar Rx LLC | 72603-814 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Northstar Rx LLC | 72603-815 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-262 |
| vilazodone hydrochloride | Vilazodone hydrochloride 10 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-260 |
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-261 |
| vilazodone hydrochloride | Vilazodone hydrochloride 10 mg/1 | TabletOral | Apotex Corp. | 60505-4372 |
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Apotex Corp. | 60505-4373 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Apotex Corp. | 60505-4374 |