Prescription drug · ANDA
Naproxen NDC 51655-457
Naproxen 500 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-457-20 | 51655045720 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-457-20)Marketed from Jul 3, 2023 | |
| 51655-457-25 | 51655045725 | 60 TABLET in 1 BOTTLE, PLASTIC (51655-457-25)Marketed from May 4, 2023 | |
| 51655-457-26 | 51655045726 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-457-26)Marketed from Jun 15, 2023 | |
| 51655-457-52 | 51655045752 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-457-52)Marketed from May 4, 2023 |
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)
- Naproxen
- Generic name (nonproprietary)
- naproxen
- Active ingredients
- Naproxen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074140
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 51655-457_49edbcc6-3934-c4fa-e063-6294a90a3e48SPL ID 49edbcc6-3934-c4fa-e063-6294a90a3e48SPL set ID fb07a76b-98ce-85dd-e053-6294a90aa6a8RxCUI 198014UNII 57Y76R9ATQ
- 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
N451655045720followed by a unit qualifier and the quantityPackage 51655-0457-20. 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 are indicated for: the relief of the signs and symptoms of: • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea Naproxen tablets are a 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 are also indicated for: the relief of signs and symptoms of: • tendonitis • bursitis • acute gout the m…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074140
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 |
|---|---|---|---|---|
| Naproxennaproxen sodium | Naproxen sodium 500 mg/1 | TabletOral | Granules India Ltd | 62207-747 |
| Naproxennaproxen sodium | Naproxen sodium 250 mg/1 | TabletOral | Granules India Ltd | 62207-745 |
| Naproxennaproxen sodium | Naproxen sodium 375 mg/1 | TabletOral | Granules India Ltd | 62207-746 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-139 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-137 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-138 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-030 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Redpharm Drug | 67296-2235 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4439 |