Naproxen
- Product NDC
- 68788-8797
- 11-digit product format
- 687888797
- Labeler code
- 68788
- Product ID
- 68788-8797_9ad5813d-635f-4829-9e46-7cf61c64238f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078250
- Marketing category
- ANDA
- Marketing start
- 2025-01-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naproxen
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPROXEN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57Y76R9ATQ |
| Rxcui | 198014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8797 | NAPROXEN TABLET [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 9 package rows | 20250101_87acd650-ea8a-4396-be72-5568c4b1755c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8797-1 | 68788879701 | 100 TABLET in 1 BOTTLE (68788-8797-1) | 100 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-2 | 68788879702 | 20 TABLET in 1 BOTTLE (68788-8797-2) | 20 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-3 | 68788879703 | 30 TABLET in 1 BOTTLE (68788-8797-3) | 30 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-4 | 68788879704 | 40 TABLET in 1 BOTTLE (68788-8797-4) | 40 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-5 | 68788879705 | 15 TABLET in 1 BOTTLE (68788-8797-5) | 15 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-6 | 68788879706 | 60 TABLET in 1 BOTTLE (68788-8797-6) | 60 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-7 | 68788879707 | 14 TABLET in 1 BOTTLE (68788-8797-7) | 14 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-8 | 68788879708 | 120 TABLET in 1 BOTTLE (68788-8797-8) | 120 tablet | 2025-01-01 | No | No | Historical |
| 68788-8797-9 | 68788879709 | 90 TABLET in 1 BOTTLE (68788-8797-9) | 90 tablet | 2025-01-01 | No | No | Historical |