Naproxen Sodium
- Product NDC
- 71205-631
- 11-digit product format
- 712050631
- Labeler code
- 71205
- Product ID
- 71205-631_0c969467-9318-4dd2-945e-95ec8092a0fe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA212199
- Marketing category
- ANDA
- Marketing start
- 2019-10-30
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-631-15 | 71205063115 | 15 TABLET in 1 BOTTLE (71205-631-15) | 15 tablet | 2022-01-20 | No | No | Historical |
| 71205-631-30 | 71205063130 | 30 TABLET in 1 BOTTLE (71205-631-30) | 30 tablet | 2022-01-20 | No | No | Historical |
| 71205-631-60 | 71205063160 | 60 TABLET in 1 BOTTLE (71205-631-60) | 60 tablet | 2022-01-20 | No | No | Historical |
| 71205-631-90 | 71205063190 | 90 TABLET in 1 BOTTLE (71205-631-90) | 90 tablet | 2022-01-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen Sodium | Proficient Rx LP | 2022-07-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |