Prescription drug · ANDA
Naproxen NDC 51655-621
Naproxen 500 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-621-20 | 51655062120 | 20 TABLET in 1 BOTTLE, PLASTIC (51655-621-20)Marketed from Jul 6, 2020 | |
| 51655-621-25 | 51655062125 | 60 TABLET in 1 BOTTLE, PLASTIC (51655-621-25)Marketed from Jul 6, 2020 | |
| 51655-621-83 | 51655062183 | 180 TABLET in 1 BOTTLE, PLASTIC (51655-621-83)Marketed from Jul 6, 2020 |
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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091416
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 51655-621_494f2182-140c-e7cc-e063-6394a90a093aSPL ID 494f2182-140c-e7cc-e063-6394a90a093aSPL set ID f32d755e-4984-ee40-e053-2995a90a4ebeRxCUI 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
N451655062120followed by a unit qualifier and the quantityPackage 51655-0621-20. 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 .
Indications (excerpt from the label)
CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISKS OF NAPROXEN AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE NAPROXEN TABLETS. USE THE LOWEST EFFECTIVE DOSE 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 SYMPTOMS OF TENDONITIS FOR RELIEF OF…
Excerpt only. Read the full label for complete information.
About NDC 51655-621
- What is NDC 51655-621?
- 51655-621 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 3 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?
- Northwind Health Company, LLC, NDC labeler code 51655. 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 091416
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 | MARKSANS PHARMA LIMITED | 25000-139 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-140 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4006 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-436 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | TIME CAP LABORATORIES | 49483-618 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | TIME CAP LABORATORIES | 49483-617 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-138 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | TIME CAP LABORATORIES | 49483-619 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0255 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | QPharma Inc | 42708-140 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4381 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4510 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0973 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-042 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | DIRECT RX | 72189-136 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0048 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-920 |