Prescription drug · ANDA
Naproxen NDC 25000-139
Naproxen 375 mg/1 · Tablet · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-139-03 | 25000013903 | 30 TABLET in 1 BOTTLE (25000-139-03)Marketed from Feb 28, 2011 | |
| 25000-139-14 | 25000013914 | 1000 TABLET in 1 BOTTLE (25000-139-14)Marketed from Feb 28, 2011 | |
| 25000-139-22 | 25000013922 | 4 BAG in 1 BOX (25000-139-22) / 4500 TABLET in 1 BAGMarketed from Feb 28, 2011 | |
| 25000-139-32 | 25000013932 | 6 BAG in 1 BOX (25000-139-32) / 4500 TABLET in 1 BAGMarketed from Feb 28, 2011 | |
| 25000-139-98 | 25000013998 | 1 BAG in 1 BOX (25000-139-98) / 25300 TABLET in 1 BAGMarketed from Feb 28, 2011 |
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
- MARKSANS PHARMA LIMITEDNDC labeler code 25000
- 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 25000-139_e5013319-e2f4-4cd0-9523-1ffd352fe2d9SPL ID e5013319-e2f4-4cd0-9523-1ffd352fe2d9SPL set ID 1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8RxCUI 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
N425000013903followed by a unit qualifier and the quantityPackage 25000-0139-03. 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 · tendonitis · bursitis · acute gout the management of · pain · primary dysmenorrhea Naproxen Tablets, USP is a non-steroidal anti-inflammatory drug indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis tendonitis bursitis acute gout the management of: pain primary dysmenorrhea
Excerpt only. Read the full label for complete information.
About NDC 25000-139
- What is NDC 25000-139?
- 25000-139 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 5 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?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-621 |
| 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 |