Esomeprazole Magnesium
- Product NDC
- 50268-272
- 11-digit product format
- 502680272
- Labeler code
- 50268
- Product ID
- 50268-272_4e5dd4ae-fc3a-2f4c-e063-6294a90a0d0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA078279
- Marketing category
- ANDA
- Marketing start
- 2026-03-23
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Esomeprazole Magnesium
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESOMEPRAZOLE MAGNESIUM | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606730 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-272-11 | Esomeprazole Magnesium | 1 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 1 | | 2 |
| 50268-272-13 | Esomeprazole Magnesium | 30 in 1 BOX | CAPSULE, DELAYED RELEASE | 30 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-272-11 | 50268027211 | 1 in 1 BLISTER PACK | | | | | Historical |
| 50268-272-13 | 50268027213 | 30 BLISTER PACK in 1 BOX (50268-272-13) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-272-11) | 30 blister pack | 2026-03-23 | No | No | Historical |