Prescription drug · ANDA
Naproxen NDC 71205-060
Naproxen 375 mg/1 · Tablet, Delayed release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-060-14 | 71205006014 | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-14)Marketed from Jun 1, 2018 | |
| 71205-060-15 | 71205006015 | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-15)Marketed from Jun 1, 2018 | |
| 71205-060-20 | 71205006020 | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-20)Marketed from Jun 1, 2018 | |
| 71205-060-30 | 71205006030 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-30)Marketed from Jun 1, 2018 | |
| 71205-060-40 | 71205006040 | 40 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-40)Marketed from Jun 1, 2018 | |
| 71205-060-45 | 71205006045 | 45 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-45)Marketed from Jun 1, 2018 | |
| 71205-060-60 | 71205006060 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-60)Marketed from Jun 1, 2018 | |
| 71205-060-90 | 71205006090 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-90)Marketed from Jun 1, 2018 |
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, Delayed release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091432
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-060_6b4c9ec2-308f-4b60-941c-34a2c7a7882cSPL ID 6b4c9ec2-308f-4b60-941c-34a2c7a7882cSPL set ID 69a3afd6-d64b-4f07-b848-b0d3fc19f2a2RxCUI 603103UNII 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
N471205006014followed by a unit qualifier and the quantityPackage 71205-0060-14. 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)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals ( see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Naproxen delayed-release tablets are indicated: • For the relief of the signs and symptoms of rheumatoid arthritis • For the relief of the signs and symptoms of osteoarthritis • For the relief of the signs and symptoms of ankylosing spondylitis • For the relief of the signs and symptoms of juvenile arthritis Naproxen del…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091432
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 | Tablet, Delayed releaseOral | NuCare Pharmaceuticals,Inc. | 66267-373 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-003 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2275 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2276 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Cipla USA Inc. | 69097-851 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Cipla USA Inc. | 69097-852 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-211 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-212 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-454 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Cameron Pharmaceuticals | 42494-453 |