Prescription drug · ANDA
Fluvoxamine Maleate NDC 60505-0164
Fluvoxamine maleate 25 mg/1 · Tablet · Oral · Apotex Corp
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60505-0164-1 | 60505016401 | 100 TABLET in 1 BOTTLE (60505-0164-1)Marketed from Jul 10, 2001 |
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 — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Apotex Corp
- 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 60505-0164_2aa18614-fba5-8c56-f4fd-e8cb590e2284SPL ID 2aa18614-fba5-8c56-f4fd-e8cb590e2284
- 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
N460505016401followed by a unit qualifier and the quantityPackage 60505-0164-01. 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
The FDA listing for this product does not reference a label (SPL) set.
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 50 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1974 |
| 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 |