Esomeprazole Magnesium
- Product NDC
- 80425-0331
- 11-digit product format
- 804250331
- Labeler code
- 80425
- Product ID
- 80425-0331_2a9b9724-0260-e829-e063-6394a90a1c07
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA211977
- Marketing category
- ANDA
- Marketing start
- 2023-05-02
- 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 |
|---|
| 80425-0331-1 | 80425033101 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-1) | 2023-05-02 | No | No | Historical |
| 80425-0331-2 | 80425033102 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-2) | 2023-05-02 | No | No | Historical |
| 80425-0331-3 | 80425033103 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0331-3) | 2023-05-02 | No | No | Historical |