Prescription drug · ANDA
Fluvoxamine Maleate NDC 73190-066
Fluvoxamine maleate 100 mg/1 · Capsule, Extended release · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73190-066-30 | 73190006630 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-066-30)Marketed from Dec 4, 2025 |
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)
- Fluvoxamine Maleate
- Generic name (nonproprietary)
- fluvoxamine maleate
- Active ingredients
- Fluvoxamine maleate — 100 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- AvKARE
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091482
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 73190-066_45279386-bef9-3bab-e063-6294a90aee92SPL ID 45279386-bef9-3bab-e063-6294a90aee92SPL set ID 4527a684-51c0-1858-e063-6394a90a2631RxCUI 903873, 903879UNII 5LGN83G74V
- Pharmacologic class
- Serotonin Reuptake 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
N473190006630followed by a unit qualifier and the quantityPackage 73190-0066-30. 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)
Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1 ). Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1 , 14.3 ). One maintenance study with IR fluvoxamine tablets ( 14.2 ). 1.1 Obsessive Compulsive Disorder Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091482
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 |
|---|---|---|---|---|
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-2848 |
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Actavis Pharma, Inc. | 0228-2849 |
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-067 |