Naproxen Sodium
- Product NDC
- 53002-5330
- 11-digit product format
- 530025330
- Labeler code
- 53002
- Product ID
- 53002-5330_413964d2-6000-41e6-bf91-fb720224636d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA200629
- Marketing category
- ANDA
- Marketing start
- 2011-10-31
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 550 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 |
|---|
| 9TN87S3A3C | NAPROXEN SODIUM | 26159-34-2 | NAPROXEN SODIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-5330-1 | 53002533001 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-5330-1) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-5330-2 | 53002533002 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-5330-2) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-5330-3 | 53002533003 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-5330-3) | 2021-01-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen Sodium | RPK Pharmaceuticals, Inc. | 2022-03-30 | Human Prescription Drug Label | 1 |