Prescription drug · ANDA
Naproxen Sodium NDC 80425-0574
Naproxen sodium 550 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0574-1 | 80425057401 | 30 TABLET in 1 BOTTLE (80425-0574-1)Marketed from Feb 4, 2026 | |
| 80425-0574-2 | 80425057402 | 60 TABLET in 1 BOTTLE (80425-0574-2)Marketed from Feb 4, 2026 | |
| 80425-0574-3 | 80425057403 | 90 TABLET in 1 BOTTLE (80425-0574-3)Marketed from Feb 4, 2026 |
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)
- Naproxen Sodium
- Generic name (nonproprietary)
- naproxen sodium
- Active ingredients
- Naproxen sodium — 550 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212199
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0574_4a05c9b4-e04e-2ab1-e063-6294a90a34f6SPL ID 4a05c9b4-e04e-2ab1-e063-6294a90a34f6SPL set ID 4a05ca8c-1b03-fa86-e063-6394a90a4119RxCUI 849431UNII 9TN87S3A3C
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N480425057401followed by a unit qualifier and the quantityPackage 80425-0574-01. 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)
Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis Naproxen sodium tablets are also indicated for: the relief of the signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • polyarticular juvenile idiopathic arthritis Naproxen sodium tablets are also indicated for: the relief of the signs and s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212199
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 |
|---|---|---|---|---|
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-627 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-637 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Proficient Rx LP | 71205-631 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8516 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8517 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-801 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0531 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2333 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-389 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9663 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-432 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-433 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7800 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Direct Rx | 72189-332 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2294 |