Esomeprazole Magnesium
- Product NDC
- 37808-364
- 11-digit product format
- 378080364
- Labeler code
- 37808
- Product ID
- 37808-364_eeab6a1c-15f1-740c-1aa8-794b54e7d9c0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- H E B
- Application
- ANDA207198
- Marketing category
- ANDA
- Marketing start
- 2025-03-01
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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 |
|---|
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | ESOMEPRAZOLE MAGNESIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 37808-364-14 | 37808036414 | 1 BOTTLE in 1 CARTON (37808-364-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2025-03-01 | No | No | Historical |
| 37808-364-28 | 37808036428 | 2 BOTTLE in 1 CARTON (37808-364-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2025-03-01 | No | No | Historical |
| 37808-364-42 | 37808036442 | 3 BOTTLE in 1 CARTON (37808-364-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2025-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | H E B | 2025-10-28 | HUMAN OTC DRUG LABEL | 3 |
| Drug Facts | H E B | 2024-10-23 | HUMAN OTC DRUG LABEL | 2 |