Prescription drug · ANDA
naproxen NDC 69097-854
Naproxen 375 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-854-07 | 69097085407 | 100 TABLET in 1 BOTTLE (69097-854-07)Marketed from Jul 5, 2016 | |
| 69097-854-12 | 69097085412 | 500 TABLET in 1 BOTTLE (69097-854-12)Marketed from Jul 5, 2016 |
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
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091305
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-854_598c64ad-f0c4-495e-b2c2-cde215d2572dSPL ID 598c64ad-f0c4-495e-b2c2-cde215d2572dSPL set ID a9549a47-3fa4-4a2b-95ac-b00e43aedae7RxCUI 198012, 198013, 198014UNII 57Y76R9ATQUPC 0369097855079, 0369097854072, 0369097853075
- 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
N469097085407followed by a unit qualifier and the quantityPackage 69097-0854-07. 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 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 management of: pain primary dysmeno…
Excerpt only. Read the full label for complete information.
About NDC 69097-854
- What is NDC 69097-854?
- 69097-854 is the product NDC for naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, 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?
- Cipla USA Inc., NDC labeler code 69097. 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?
- 185 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 | 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 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Medcore LLC | 82461-711 | 82461-0711-60 |
| Naproxen | Naproxen 125 mg/5mL | SuspensionOral | Aurobindo Pharma Limited | 59651-528 | 59651-0528-47 |
Other NDCs under ANDA 091305
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 | Exelan Pharmaceuticals, Inc. | 76282-341 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-340 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-342 |
| naproxen | Naproxen 250 mg/1 | TabletOral | Cipla USA Inc. | 69097-853 |
| naproxen | Naproxen 500 mg/1 | TabletOral | Cipla USA Inc. | 69097-855 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-218 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-211 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-216 |