Naproxen
- Product NDC
- 53002-3241
- 11-digit product format
- 530023241
- Labeler code
- 53002
- Product ID
- 53002-3241_984d2f71-6047-4826-905f-7545f33a3711
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA078250
- Marketing category
- ANDA
- Marketing start
- 2007-07-01
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN
- Active strength
- 250 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-3241-2 | 53002324102 | 20 TABLET in 1 BOTTLE (53002-3241-2) | 20 tablet | 2022-01-01 | 0000-00-00 | No | No | Current |
| 53002-3241-3 | 53002324103 | 30 TABLET in 1 BOTTLE (53002-3241-3) | 30 tablet | 2022-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen | RPK Pharmaceuticals, Inc. | 2022-03-30 | HUMAN PRESCRIPTION DRUG LABEL | 4 |