Prescription drug · NDA AUTHORIZED GENERIC
fluvoxamine maleate NDC 62559-159
Fluvoxamine maleate 50 mg/1 · Tablet, Coated · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-159-01 | 6255901590162559015901 | 100 TABLET, COATED in 1 BOTTLE (62559-159-01)Marketed from Aug 9, 2011 |
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 — 50 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 62559
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021519
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 62559-159_cfb2098d-d30b-4a8e-84c1-aeb8065b519cSPL ID cfb2098d-d30b-4a8e-84c1-aeb8065b519cSPL set ID 7ecd83ec-88f5-4f85-9cc2-9068375d8820RxCUI 903884, 903887, 903891UNII 5LGN83G74VUPC 0362559159012, 0362559158015, 0362559160018
- 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
N462559015901followed by a unit qualifier and the quantityPackage 62559-0159-01. 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.
About NDC 62559-159
- What is NDC 62559-159?
- 62559-159 is the product NDC for fluvoxamine maleate, Fluvoxamine maleate 50 mg/1 tablet, coated, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- fluvoxamine maleate.
- What is the active ingredient?
- Fluvoxamine maleate.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for fluvoxamine maleate?
- 37 other product NDCs are listed under this name. See all fluvoxamine maleate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other fluvoxamine maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-6026 | 00832-6026-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-6025 | 00832-6025-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-066 | 73190-0066-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-067 | 73190-0067-30 |
| Fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4011 | 68788-4011-0368788-4011-0668788-4011-09 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-064 | 31722-0064-0131722-0064-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-065 | 31722-0065-0131722-0065-30 |
| Fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7728 | 50090-7728-00 |
| Fluvoxamine maleate | Fluvoxamine maleate 25 mg/1 | TabletOral | Bionpharma Inc. | 69452-454 | 69452-0454-2069452-0454-3069452-0454-32 |
| Fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | Bionpharma Inc. | 69452-455 | 69452-0455-2069452-0455-3069452-0455-32 |
Other NDCs under NDA 021519
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 | Tablet, CoatedOral | A-S Medication Solutions | 50090-5988 |
| fluvoxamine maleate | Fluvoxamine maleate 25 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-158 |
| fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | Tablet, CoatedOral | ANI Pharmaceuticals, Inc. | 62559-160 |
| fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | Tablet, CoatedOral | Preferred Pharmaceuticals, Inc. | 68788-7219 |
| fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-1057 |
| fluvoxamine maleate | Fluvoxamine maleate 50 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-1643 |