esomeprazole magnesium
- Product NDC
- 72657-127
- 11-digit product format
- 726570127
- Labeler code
- 72657
- Product ID
- 72657-127_da5ec2c4-833e-4d2a-a61f-b43835c7f473
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- GLENMARK THERAPEUTICS INC., USA
- Application
- ANDA216349
- Marketing category
- ANDA
- Marketing start
- 2023-08-22
- Substance
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
- 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 TRIHYDRATE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R6DXU4WAY9 |
| Rxcui | 606726 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72657-127-42 | esomeprazole magnesium | 3 in 1 CARTON | CAPSULE, DELAYED RELEASE | 3 | | 2 |
| 72657-127-42 | esomeprazole magnesium | 14 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 14 | | 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 |
|---|
| 72657-127-42 | 72657012742 | 3 BOTTLE in 1 CARTON (72657-127-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2025-08-06 | No | No | Historical |