Prescription drug · ANDA
Naproxen sodium NDC 71335-1650
Naproxen sodium 550 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1650-0 | 71335165000 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-1650-0)Marketed from Aug 12, 2024 | |
| 71335-1650-1 | 71335165001 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1650-1)Marketed from Aug 12, 2024 | |
| 71335-1650-2 | 71335165002 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1650-2)Marketed from Aug 12, 2024 | |
| 71335-1650-3 | 71335165003 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1650-3)Marketed from Jun 23, 2020 | |
| 71335-1650-4 | 71335165004 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1650-4)Marketed from Aug 12, 2024 | |
| 71335-1650-5 | 71335165005 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1650-5)Marketed from Aug 12, 2024 | |
| 71335-1650-6 | 71335165006 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1650-6)Marketed from Aug 12, 2024 | |
| 71335-1650-7 | 71335165007 | 42 TABLET, FILM COATED in 1 BOTTLE (71335-1650-7)Marketed from Aug 12, 2024 | |
| 71335-1650-8 | 71335165008 | 14 TABLET, FILM COATED in 1 BOTTLE (71335-1650-8)Marketed from Aug 12, 2024 | |
| 71335-1650-9 | 71335165009 | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1650-9)Marketed from Aug 12, 2024 |
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, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078486
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1650_2bd1f190-c76c-4003-9ab9-1c6c27dde97aSPL ID 2bd1f190-c76c-4003-9ab9-1c6c27dde97aSPL set ID 42f6a3a0-5a1e-40ca-8949-b8870dd95d2eRxCUI 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
N471335165000followed by a unit qualifier and the quantityPackage 71335-1650-00. 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 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 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 signs and symptoms of: • tendonitis • b…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078486
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 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5238 |
| Naproxen sodium | Naproxen sodium 275 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-494 |
| Naproxen sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-495 |
| Naproxen sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | PHOENIX RX LLC | 85509-1495 |
| Naproxen sodium | Naproxen sodium 550 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 55700-625 |