Esomeprazole Magnesium
- Product NDC
- 0615-8628
- 11-digit product format
- 006158628
- Labeler code
- 0615
- Product ID
- 0615-8628_ecc7a3a6-7ef1-41a1-a779-727f16220695
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA205606
- Marketing category
- ANDA
- Marketing start
- 2023-11-20
- Substance
- ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
- 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 TRIHYDRATE | 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 |
|---|
| 0615-8628-39 | Esomeprazole Magnesium | 30 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8628-39 | 00615862839 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8628-39) | 2026-04-02 | No | No | Current |