Esomeprazole Magnesium
- Product NDC
- 69238-1050
- 11-digit product format
- 692381050
- Labeler code
- 69238
- Product ID
- 69238-1050_6d99ea99-c097-4ac3-ab97-53ce247f56fb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209716
- Marketing category
- ANDA
- Marketing start
- 2019-06-05
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1050 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC] | 7 | Legacy NDC | 20241116_d13c22be-f5bd-4ea8-8081-bdfac9e7fb1b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69238-1050-1 | 69238105001 | 1 BOTTLE in 1 BLISTER PACK (69238-1050-1) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) | 1 bottle | 2019-06-05 | 0000-00-00 | No | No | Current |
| 69238-1050-2 | 69238105002 | 2 BOTTLE in 1 CARTON (69238-1050-2) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) | 2 bottle | 2019-06-05 | 0000-00-00 | No | No | Current |
| 69238-1050-3 | 69238105003 | 3 BOTTLE in 1 CARTON (69238-1050-3) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) | 3 bottle | 2019-06-05 | 0000-00-00 | No | No | Current |
| 69238-1050-5 | 69238105005 | 1 BOTTLE in 1 CARTON (69238-1050-5) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) | 1 bottle | 2019-06-05 | 0000-00-00 | No | No | Current |
| 69238-1050-8 | 69238105008 | 3 BOTTLE in 1 BLISTER PACK (69238-1050-8) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) | 3 bottle | 2019-06-05 | 0000-00-00 | No | No | Current |
| 69238-1050-9 | 69238105009 | 2 BOTTLE in 1 BLISTER PACK (69238-1050-9) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4) | 2 bottle | 2019-06-05 | 0000-00-00 | No | No | Current |