Naproxen
- Product NDC
- 68788-8602
- 11-digit product format
- 687888602
- Labeler code
- 68788
- Product ID
- 68788-8602_f6aaf43d-d2fe-45a6-b984-e3909c5e75de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA212517
- Marketing category
- ANDA
- Marketing start
- 2024-04-01
- Substance
- NAPROXEN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 57Y76R9ATQ | NAPROXEN | 22204-53-1 | NAPROXEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8602-1 | 68788860201 | 100 TABLET in 1 BOTTLE (68788-8602-1) | 100 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-2 | 68788860202 | 20 TABLET in 1 BOTTLE (68788-8602-2) | 20 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-3 | 68788860203 | 30 TABLET in 1 BOTTLE (68788-8602-3) | 30 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-4 | 68788860204 | 40 TABLET in 1 BOTTLE (68788-8602-4) | 40 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-5 | 68788860205 | 15 TABLET in 1 BOTTLE (68788-8602-5) | 15 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-6 | 68788860206 | 60 TABLET in 1 BOTTLE (68788-8602-6) | 60 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-7 | 68788860207 | 14 TABLET in 1 BOTTLE (68788-8602-7) | 14 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-8 | 68788860208 | 120 TABLET in 1 BOTTLE (68788-8602-8) | 120 tablet | 2024-04-01 | No | No | Historical |
| 68788-8602-9 | 68788860209 | 90 TABLET in 1 BOTTLE (68788-8602-9) | 90 tablet | 2024-04-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen | Preferred Pharmaceuticals Inc. | 2025-08-18 | HUMAN PRESCRIPTION DRUG LABEL | 2 |