Prescription drug · ANDA
Fluvoxamine Maleate NDC 71335-1974
Fluvoxamine maleate 50 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1974-1 | 71335197401 | 60 TABLET in 1 BOTTLE (71335-1974-1)Marketed from Feb 14, 2022 | |
| 71335-1974-2 | 71335197402 | 30 TABLET in 1 BOTTLE (71335-1974-2)Marketed from Oct 14, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075902
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1974_edc23496-df64-4284-9f04-f2b35bf19c00SPL ID edc23496-df64-4284-9f04-f2b35bf19c00SPL set ID 47daea9e-545d-4a67-b2b2-d12c3c98734bRxCUI 903891UNII 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
N471335197401followed by a unit qualifier and the quantityPackage 71335-1974-01. 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 tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) ( 1 ). 1.1 Obsessive-Compulsive Disorder Fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in DSM-III-R or DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional beh…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075902
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 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8175 |
| Fluvoxamine Maleate | Fluvoxamine maleate 50 mg/1 | TabletOral | American Health Packaging | 68084-837 |
| Fluvoxamine Maleate | Fluvoxamine maleate 25 mg/1 | TabletOral | Apotex Corp | 60505-0164 |
| Fluvoxamine Maleate | Fluvoxamine maleate 50 mg/1 | TabletOral | Apotex Corp | 60505-0165 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | Apotex Corp | 60505-0166 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-221 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2008 |