Prescription drug · ANDA
Vilazodone Hydrochloride NDC 0480-2044
Vilazodone hydrochloride 20 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-2044-56 | 00480204456 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-2044-56)Marketed from Jun 6, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208212
- Marketing start
- Listing expires
- Identifiers
- Product ID 0480-2044_5e283aac-a23f-4dd5-870e-19ca577b9000SPL ID 5e283aac-a23f-4dd5-870e-19ca577b9000SPL set ID 3a4745a0-de23-4b40-923e-0d7dfe6b8634RxCUI 1086772, 1086778, 1086784UNII U8HTX2GK8J
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
N400480204456followed by a unit qualifier and the quantityPackage 00480-2044-56. 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 208212
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 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-916 |
| Vilazodone Hydrochloride | Vilazodone hydrochloride 10 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-915 |
| Vilazodone Hydrochloride | Vilazodone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-917 |
| Vilazodone Hydrochloride | Vilazodone hydrochloride 40 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2043 |
| Vilazodone Hydrochloride | Vilazodone hydrochloride 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-2045 |