esomeprazole magnesium
- Product NDC
- 68071-3419
- 11-digit product format
- 680713419
- Labeler code
- 68071
- Product ID
- 68071-3419_2d5851ff-390a-1691-e063-6394a90a6e50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA213486
- Marketing category
- ANDA
- Marketing start
- 2021-03-19
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3419-6 | 68071341906 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3419-6) | 2023-06-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| esomeprazole magnesium | NuCare Pharmaceuticals,Inc. | 2025-02-04 | HUMAN PRESCRIPTION DRUG LABEL | 2 |