Esomeprazole Magnesium
- Product NDC
- 58602-846
- 11-digit product format
- 586020846
- Labeler code
- 58602
- Product ID
- 58602-846_ec1a0eff-d2ba-4300-b764-60f8df58e82c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aurohealth LLC
- Application
- ANDA209339
- Marketing category
- ANDA
- Marketing start
- 2020-05-16
- 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 |
|---|
| 58602-846-05 | 58602084605 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (58602-846-05) | | 2020-05-16 | No | No | Historical |
| 58602-846-62 | 58602084662 | 3 BOTTLE in 1 CARTON (58602-846-62) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2020-05-16 | No | No | Historical |