Esomeprazole Magnesium
- Product NDC
- 50090-5134
- 11-digit product format
- 500905134
- Labeler code
- 50090
- Product ID
- 50090-5134_006cdc3e-9071-44fa-8394-707f05018c9b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA078279
- Marketing category
- ANDA
- Marketing start
- 2019-09-17
- 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 |
|---|
| 50090-5134-0 | 50090513400 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-0) | 2023-12-15 | No | No | Historical |
| 50090-5134-1 | 50090513401 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5134-1) | 2020-08-18 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Esomeprazole Magnesium | A-S Medication Solutions | 2023-12-27 | HUMAN PRESCRIPTION DRUG LABEL | 5 |