Esomeprazole Magnesium
- Product NDC
- 59651-804
- 11-digit product format
- 596510804
- Labeler code
- 59651
- Product ID
- 59651-804_e691b51e-2e31-4408-81c4-5afec6f9bbb6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- GRANULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA218948
- Marketing category
- ANDA
- Marketing start
- 2025-04-15
- Substance
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
- Active strength
- 20 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 |
|---|
| 59651-804-30 | 59651080430 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-804-30) | 2025-04-15 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Esomeprazole Magnesium | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2025-04-16 | Human Prescription Drug Label | 1 |