Esomeprazole Magnesium
- Product NDC
- 51316-563
- 11-digit product format
- 513160563
- Labeler code
- 51316
- Product ID
- 51316-563_39a6ed03-0253-3a4a-7736-47cc86bf6ba0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- ANDA211571
- Marketing category
- ANDA
- Marketing start
- 2025-08-30
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 433733 |
DailyMed Product Concepts#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51316-563-14 | 51316056314 | 1 BOTTLE in 1 CARTON (51316-563-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2025-08-30 | No | No | Historical |
| 51316-563-42 | 51316056342 | 3 BOTTLE in 1 CARTON (51316-563-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2025-08-30 | No | No | Historical |