esomeprazole magnesium
- Product NDC
- 42507-774
- 11-digit product format
- 425070774
- Labeler code
- 42507
- Product ID
- 42507-774_bf94aa95-9b11-496b-9f75-1d0c5df15d2e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- esomeprazole magnesium dihydrate
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA207193
- Marketing category
- ANDA
- Marketing start
- 2026-01-28
- 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
- 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 DIHYDRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 36H71644EQ |
| Rxcui | 606726 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-774-00 | esomeprazole magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 2 |
| 42507-774-42 | esomeprazole magnesium | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | | 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 |
|---|
| 42507-774-00 | 42507077400 | 14 in 1 BOTTLE | | | | | Historical |
| 42507-774-42 | 42507077442 | 3 BOTTLE in 1 CARTON (42507-774-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42507-774-00) | 3 bottle | 2026-01-28 | No | No | Current |