Naproxen and esomeprazole magnesium
- Product NDC
- 76420-889
- 11-digit product format
- 764200889
- Labeler code
- 76420
- Product ID
- 76420-889_2a4fb535-ba1a-05d6-e063-6394a90a0b29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Naproxen and esomeprazole magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA204206
- Marketing category
- ANDA
- Marketing start
- 2020-02-18
- Substance
- ESOMEPRAZOLE MAGNESIUM; 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 |
|---|
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | ESOMEPRAZOLE MAGNESIUM |
| 57Y76R9ATQ | NAPROXEN | 22204-53-1 | NAPROXEN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-889-01 | 76420088901 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-01) | 2024-12-28 | No | No | Historical |
| 76420-889-30 | 76420088930 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-30) | 2024-12-28 | No | No | Historical |
| 76420-889-60 | 76420088960 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-60) | 2024-12-28 | No | No | Historical |
| 76420-889-90 | 76420088990 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-889-90) | 2024-12-28 | No | No | Historical |