Naproxen and esomeprazole magnesium
- Product NDC
- 68788-4043
- 11-digit product format
- 687884043
- Labeler code
- 68788
- Product ID
- 68788-4043_6368a3be-4b79-466b-8ec4-11fc3ac623cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen and esomeprazole magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA204206
- Marketing category
- ANDA
- Marketing start
- 2025-10-17
- Substance
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAPROXEN
- Active strength
- 20; 500 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-4043-3 | 68788404303 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-3) | 2025-10-17 | No | No | Historical |
| 68788-4043-6 | 68788404306 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-6) | 2025-10-17 | No | No | Historical |