Naproxen
- Product NDC
- 67046-1553
- 11-digit product format
- 670461553
- Labeler code
- 67046
- Product ID
- 67046-1553_3375e0d7-07c2-6489-e063-6294a90a91ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA200429
- Marketing category
- ANDA
- Marketing start
- 2025-04-23
- 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
- 2026-12-31
- Current FDA listing
- Yes
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 | Sample | Exclude flag | Status |
|---|
| 67046-1553-3 | 67046155303 | 30 TABLET in 1 BLISTER PACK (67046-1553-3) | 30 tablet | 2025-04-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Naproxen | Coupler LLC | 2025-04-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |