Prescription drug · ANDA
Naproxen NDC 68788-7946
Naproxen 375 mg/1 · Tablet · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7946-1 | 68788794601 | 100 TABLET in 1 BOTTLE (68788-7946-1)Marketed from Jun 28, 2021 | |
| 68788-7946-2 | 68788794602 | 20 TABLET in 1 BOTTLE (68788-7946-2)Marketed from Jun 28, 2021 | |
| 68788-7946-3 | 68788794603 | 30 TABLET in 1 BOTTLE (68788-7946-3)Marketed from Jun 28, 2021 | |
| 68788-7946-6 | 68788794606 | 60 TABLET in 1 BOTTLE (68788-7946-6)Marketed from Jun 28, 2021 | |
| 68788-7946-8 | 68788794608 | 120 TABLET in 1 BOTTLE (68788-7946-8)Marketed from Jun 28, 2021 | |
| 68788-7946-9 | 68788794609 | 90 TABLET in 1 BOTTLE (68788-7946-9)Marketed from Jun 28, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212517
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-7946_5ed47a34-76fb-4e17-9306-94bc10bc2c0cSPL ID 5ed47a34-76fb-4e17-9306-94bc10bc2c0cSPL set ID 9f026fd5-f996-4383-b528-841d38d3dab5RxCUI 198012UNII 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
N468788794601followed by a unit qualifier and the quantityPackage 68788-7946-01. 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 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 • tendonitis • bursitis • acute gout the management of: • pain • primary dysmenorrhea
Excerpt only. Read the full label for complete information.
About NDC 68788-7946
- What is NDC 68788-7946?
- 68788-7946 is the product NDC for Naproxen, Naproxen 375 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 6 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 212517
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 | Sportpharm LLC | 85766-106 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-592 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1869 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | Sportpharm LLC | 85766-105 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-591 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Sportpharm LLC | 85766-107 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-597 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8602 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-657 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-5646 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2396 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-5645 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0024 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-5649 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | HAWAII REPACK, INC. | 85534-0023 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3486 |
| Naproxen | Naproxen 250 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-434 |
| Naproxen | Naproxen 375 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-435 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc. | 50228-436 |
| Naproxen | Naproxen 500 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-743 |
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