Esomeprazole Magnesium
- Product NDC
- 0615-8396
- 11-digit product format
- 006158396
- Labeler code
- 0615
- Product ID
- 0615-8396_0300c30b-ed64-4d94-8ccc-c77ea3ad4419
- 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
- 2016-04-21
- Marketing end
- 2026-05-31
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8396-39 | Esomeprazole Magnesium | 30 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 30 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8396 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 14 | Current NDC, Legacy NDC, 1 package rows | 20240918_213ccff1-4982-426b-a4f8-ecb2f2ee6dc6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8396-39 | 00615839639 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8396-39) | 2021-06-22 | 2026-05-31 | No | No | Current |