Prescription drug · ANDA
Vilazodone Hydrochloride NDC 76282-544
Vilazodone hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Exelan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-544-30 | 76282054430 | 30 TABLET, FILM COATED in 1 BOTTLE (76282-544-30)Marketed from Dec 1, 2022 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208200
- Marketing start
- Listing expires
- Identifiers
- Product ID 76282-544_da0f5799-ae08-4f50-b909-96c73adeeb31SPL ID da0f5799-ae08-4f50-b909-96c73adeeb31SPL set ID d1d8b51c-823b-4702-a726-a7530abd8957RxCUI 1086772, 1086778, 1086784UNII U8HTX2GK8JUPC 0376282545301, 0376282544304, 0376282546308
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
N476282054430followed by a unit qualifier and the quantityPackage 76282-0544-30. 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 is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Vilazodone hydrochloride is 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 208200
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 40 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-982 |
| Vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-545 |
| Vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-546 |
| Vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-981 |
| Vilazodone Hydrochloride | Vilazodone hydrochloride 10 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-979 |