Esomeprazole Magnesium
- Product NDC
- 72789-391
- 11-digit product format
- 727890391
- Labeler code
- 72789
- Product ID
- 72789-391_412329bd-ce50-d48d-e063-6294a90a9399
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078279
- Marketing category
- ANDA
- Marketing start
- 2015-12-10
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72789-391-90 | 72789039190 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-391-90) | 2024-04-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Esomeprazole Magnesium | PD-Rx Pharmaceuticals, Inc. | 2025-10-14 | HUMAN PRESCRIPTION DRUG LABEL | 14 |
| Esomeprazole Magnesium | PD-Rx Pharmaceuticals, Inc. | 2024-04-09 | HUMAN PRESCRIPTION DRUG LABEL | 13 |