Prescription drug · ANDA
Vilazodone hydrochloride NDC 69097-982
Vilazodone hydrochloride 40 mg/1 · Tablet, Film coated · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-982-02 | 6909709820269097098202 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-982-02)Marketed from Jan 23, 2023 |
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, Film coated
- Route
- Oral
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208200
- Marketing start
- Listing expires
- Identifiers
- Product ID 69097-982_e16f2d8b-a5ec-498f-97c4-d1c9d897140fSPL ID e16f2d8b-a5ec-498f-97c4-d1c9d897140fSPL set ID 658c4bc1-4128-4e0e-8852-b5f68880e8d7RxCUI 1086772, 1086778, 1086784UNII U8HTX2GK8JUPC 0369097981020, 0369097979027, 0369097982027
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
N469097098202followed by a unit qualifier and the quantityPackage 69097-0982-02. 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.
About NDC 69097-982
- What is NDC 69097-982?
- 69097-982 is the product NDC for Vilazodone hydrochloride, Vilazodone hydrochloride 40 mg/1 tablet, film coated, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vilazodone hydrochloride.
- What is the active ingredient?
- Vilazodone hydrochloride.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vilazodone hydrochloride?
- 32 other product NDCs are listed under this name. See all Vilazodone hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vilazodone hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8734 | 68788-8734-03 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8735 | 68788-8735-03 |
| vilazodone hydrochloride | Vilazodone hydrochloride 10 mg/1 | TabletOral | Apotex Corp. | 60505-4372 | 60505-4372-03 |
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Apotex Corp. | 60505-4373 | 60505-4373-03 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Apotex Corp. | 60505-4374 | 60505-4374-03 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Proficient Rx LP | 82804-128 | 82804-0128-30 |
| vilazodone hydrochloride | Vilazodone hydrochloride 10 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-260 | 72205-0260-30 |
| vilazodone hydrochloride | Vilazodone hydrochloride 20 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-261 | 72205-0261-30 |
| vilazodone hydrochloride | Vilazodone hydrochloride 40 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-262 | 72205-0262-30 |
| vilazodone hydrochloride | Vilazodone hydrochloride 10 mg/1 | TabletOral | Northstar Rx LLC | 72603-813 | 72603-0813-01 |
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 10 mg/1 | Tablet, Film coatedOral | Cipla USA Inc. | 69097-979 |
| 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 | Exelan Pharmaceuticals Inc. | 76282-544 |
| 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 |