Prescription drug · ANDA
Naproxen NDC 43353-218
Naproxen 375 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43353-218-53 | 43353021853 | 60 TABLET in 1 BOTTLE (43353-218-53)Marketed from Aug 18, 2016 | |
| 43353-218-80 | 43353021880 | 180 TABLET in 1 BOTTLE (43353-218-80)Marketed from Aug 18, 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
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
- 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 43353-218_68ef14c5-d88d-4c95-b6d4-65606f4c11faSPL ID 68ef14c5-d88d-4c95-b6d4-65606f4c11faSPL set ID e2347581-90da-429a-b17c-cffd0039fb86RxCUI 198012, 198013, 198014UNII 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
N443353021853followed by a unit qualifier and the quantityPackage 43353-0218-53. 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 tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation) . Naproxen 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 tablets are also indicated: For relief of the signs and symp…
Excerpt only. Read the full label for complete information.
About NDC 43353-218
- What is NDC 43353-218?
- 43353-218 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 500 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-342 |
| 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 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Exelan Pharmaceuticals, Inc. | 76282-340 |
| naproxen | Naproxen 375 mg/1 | TabletOral | Cipla USA Inc. | 69097-854 |
| naproxen | Naproxen 250 mg/1 | TabletOral | Cipla USA Inc. | 69097-853 |
| naproxen | Naproxen 500 mg/1 | TabletOral | Cipla USA Inc. | 69097-855 |