Prescription drug · ANDA
Naproxen Sodium NDC 80425-0532
Naproxen sodium 550 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0532-1 | 80425053201 | 30 TABLET in 1 BOTTLE (80425-0532-1)Marketed from Jun 2, 2025 | |
| 80425-0532-2 | 80425053202 | 60 TABLET in 1 BOTTLE (80425-0532-2)Marketed from Jun 2, 2025 | |
| 80425-0532-3 | 80425053203 | 90 TABLET in 1 BOTTLE (80425-0532-3)Marketed from Jun 2, 2025 |
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 078314
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 80425-0532_4aa47708-3e68-f5cc-e063-6394a90a0eb1SPL ID 4aa47708-3e68-f5cc-e063-6394a90a0eb1SPL set ID 36996557-3227-b753-e063-6394a90a7b6fRxCUI 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
N480425053201followed by a unit qualifier and the quantityPackage 80425-0532-01. 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 tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium tablets are also indicated for: the relief of signs and symptoms of: tendonitis bursitis acute gout the management of: pain primary dysmenorrhea Naproxen tablets and 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 tablets and naproxen sodium tablets are also indicated …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078314
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 | Bryant Ranch Prepack | 71335-3075 |
| Naproxen Sodium | Naproxen sodium 275 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-178 |
| Naproxen Sodium | Naproxen sodium 550 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-179 |