esomeprazole magnesium
- Product NDC
- 82804-078
- 11-digit product format
- 828040078
- Labeler code
- 82804
- Product ID
- 82804-078_7b92ac4f-50c9-4061-b4a7-535a58cea8f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA213486
- Marketing category
- ANDA
- Marketing start
- 2021-03-19
- 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 |
|---|
| 82804-078-30 | 82804007830 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-30) | 2024-02-28 | No | No | Historical |
| 82804-078-60 | 82804007860 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-60) | 2024-02-28 | No | No | Historical |
| 82804-078-90 | 82804007890 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-078-90) | 2024-02-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| esomeprazole magnesium | Proficient Rx LP | 2024-02-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |