Prescription drug · ANDA
Naproxen NDC 65162-189
Naproxen 375 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-189-10 | 65162018910 | 100 TABLET in 1 BOTTLE (65162-189-10)Marketed from Feb 18, 2010 | |
| 65162-189-11 | 65162018911 | 1000 TABLET in 1 BOTTLE (65162-189-11)Marketed from Feb 18, 2010 | |
| 65162-189-50 | 65162018950 | 500 TABLET in 1 BOTTLE (65162-189-50)Marketed from Feb 18, 2010 |
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 — 375 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075927
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 65162-189_691465d4-c26e-4118-9578-bec8d788f33bSPL ID 691465d4-c26e-4118-9578-bec8d788f33bSPL set ID c43a43e2-e867-448d-8f59-3efc7c077cbcRxCUI 198012, 198013, 198014UNII 57Y76R9ATQUPC 0365162189100, 0365162188103, 0365162190106
- 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
N465162018910followed by a unit qualifier and the quantityPackage 65162-0189-10. 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 tendonitis bursitis acute gout The management of: pain primary dysmenorrhea Naproxen 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 • tendonitis • bursitis • acute gout The management of: • pain • primary dysmenorrhea
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075927
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 | Naproxen 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0345 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7090 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-4636 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-4637 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-4638 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | AvPAK | 50268-594 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | AvPAK | 50268-595 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-8094 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-4752 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0010 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5863 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0049 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-188 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Proficient Rx LP | 63187-455 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-189 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-190 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-600 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-650 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-188 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-190 |
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