Prescription drug · ANDA
Naproxen NDC 67296-2235
Naproxen 500 mg/1 · Tablet · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2235-5 | 6729622350567296223505 | 30 TABLET in 1 BOTTLE (67296-2235-5)Marketed from Apr 15, 2021 |
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
- Generic name (nonproprietary)
- naproxen
- Active ingredients
- Naproxen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Redpharm DrugNDC labeler code 67296
- 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 67296-2235_52503511-f8a0-a932-e063-6294a90abec9SPL ID 52503511-f8a0-a932-e063-6294a90abec9SPL set ID 52503536-593e-808b-e063-6294a90a737fRxCUI 198014UNII 57Y76R9ATQUPC 0370010137011, 0370010138018, 0370010139015
- 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
N467296223505followed by a unit qualifier and the quantityPackage 67296-2235-05. 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.
About NDC 67296-2235
- What is NDC 67296-2235?
- 67296-2235 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Redpharm Drug. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Naproxen.
- What is the active ingredient?
- Naproxen.
- Who is the labeler?
- Redpharm Drug, NDC labeler code 67296. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Naproxen?
- 189 other product NDCs are listed under this name. See all Naproxen NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Naproxen products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Naproxen | Naproxen 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-092 | 87441-0092-01 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-190 | 60760-0190-60 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4750 | 70518-4750-00 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0784 | 67046-0784-03 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Coupler LLC | 67046-0499 | 67046-0499-03 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Coupler LLC | 67046-0500 | 67046-0500-03 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0501 | 67046-0501-03 |
| Naproxen | Naproxen 375 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-211 | 11534-0211-01 |
| Naproxen | Naproxen 500 mg/1 | Tablet, Delayed releaseOral | Sunrise Pharmaceutical, Inc. | 11534-212 | 11534-0212-01 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 | 70518-4514-00 |
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 |
|---|---|---|---|---|
| Naproxen | Naproxen 375 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-030 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4439 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-457 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-137 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-138 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-139 |
| 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 |
| Naproxennaproxen sodium | Naproxen sodium 500 mg/1 | TabletOral | Granules India Ltd | 62207-747 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4514 |