Esomeprazole Magnesium
- Product NDC
- 0363-0508
- 11-digit product format
- 003630508
- Labeler code
- 0363
- Product ID
- 0363-0508_e013fcf8-2ab3-4e7f-9d35-dac0acfb8766
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- WALGREEN CO.
- Application
- ANDA209339
- Marketing category
- ANDA
- Marketing start
- 2017-10-16
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- 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 |
|---|
| 36H71644EQ | ESOMEPRAZOLE MAGNESIUM DIHYDRATE | 217087-10-0 | ESOMEPRAZOLE MAGNESIUM DIHYDRATE |
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | Esomeprazole Magnesium |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0363-0508-05 | 00363050805 | 1 BOTTLE in 1 CARTON (0363-0508-05) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2017-10-16 | No | No | Historical |
| 0363-0508-08 | 00363050808 | 2 BOTTLE in 1 CARTON (0363-0508-08) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2017-10-16 | No | No | Historical |
| 0363-0508-10 | 00363050810 | 3 BOTTLE in 1 CARTON (0363-0508-10) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2017-10-16 | No | No | Historical |