Naproxen Sodium
- Product NDC
- 76420-637
- 11-digit product format
- 764200637
- Labeler code
- 76420
- Product ID
- 76420-637_07f76fa9-dba3-997b-e063-6294a90a6dd5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA212199
- Marketing category
- ANDA
- Marketing start
- 2019-10-30
- Substance
- NAPROXEN SODIUM
- Active strength
- 275 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 |
|---|
| 76420-637-01 | 76420063701 | 100 TABLET in 1 BOTTLE (76420-637-01) | 100 tablet | 2023-10-18 | No | No | Historical |
| 76420-637-30 | 76420063730 | 30 TABLET in 1 BOTTLE (76420-637-30) | 30 tablet | 2023-10-18 | No | No | Historical |
| 76420-637-60 | 76420063760 | 60 TABLET in 1 BOTTLE (76420-637-60) | 60 tablet | 2023-10-18 | No | No | Historical |
| 76420-637-90 | 76420063790 | 90 TABLET in 1 BOTTLE (76420-637-90) | 90 tablet | 2023-10-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen Sodium | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-10-18 | HUMAN PRESCRIPTION DRUG LABEL | 1 |