Prescription drug · ANDA
Naproxen NDC 63187-028
Naproxen 500 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-028-10 | 63187002810 | 10 TABLET in 1 BOTTLE (63187-028-10)Marketed from Mar 1, 2019 | |
| 63187-028-14 | 63187002814 | 14 TABLET in 1 BOTTLE (63187-028-14)Marketed from May 1, 2017 | |
| 63187-028-15 | 63187002815 | 15 TABLET in 1 BOTTLE (63187-028-15)Marketed from May 1, 2014 | |
| 63187-028-20 | 63187002820 | 20 TABLET in 1 BOTTLE (63187-028-20)Marketed from May 1, 2014 | |
| 63187-028-30 | 63187002830 | 30 TABLET in 1 BOTTLE (63187-028-30)Marketed from May 1, 2014 | |
| 63187-028-40 | 63187002840 | 40 TABLET in 1 BOTTLE (63187-028-40)Marketed from Jun 1, 2017 | |
| 63187-028-45 | 63187002845 | 45 TABLET in 1 BOTTLE (63187-028-45)Marketed from May 1, 2014 | |
| 63187-028-60 | 63187002860 | 60 TABLET in 1 BOTTLE (63187-028-60)Marketed from May 1, 2014 | |
| 63187-028-90 | 63187002890 | 90 TABLET in 1 BOTTLE (63187-028-90)Marketed from May 1, 2014 |
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
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078250
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-028_e1ba35a9-7bc6-4597-965a-7e9fbd602a9bSPL ID e1ba35a9-7bc6-4597-965a-7e9fbd602a9bSPL set ID 96601d76-50ea-4dc0-b588-d174f8d8bb51RxCUI 198014UNII 57Y76R9ATQUPC 0363187028602
- 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
N463187002810followed by a unit qualifier and the quantityPackage 63187-0028-10. 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, naproxen sodium and other treatment options before deciding to use naproxen and naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen as naproxen or naproxen sodium 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 as naproxen suspension is recommended for juvenile…
Excerpt only. Read the full label for complete information.
About NDC 63187-028
- What is NDC 63187-028?
- 63187-028 is the product NDC for Naproxen, Naproxen 500 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 9 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?
- Proficient Rx LP, NDC labeler code 63187. 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 078250
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 | TabletOral | REMEDYREPACK INC. | 70518-1516 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0095 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-190 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0217 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-1583 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | A-S Medication Solutions | 50090-2788 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-153 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-1584 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | A-S Medication Solutions | 50090-1585 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-0483 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-807 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-0481 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-0482 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-489 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | American Health Packaging | 60687-491 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8797 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Proficient Rx LP | 63187-535 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Coupler LLC | 67046-0500 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Coupler LLC | 67046-0499 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Coupler LLC | 67046-0501 |
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