esomeprazole magnesium
- Product NDC
- 68788-7591
- 11-digit product format
- 687887591
- Labeler code
- 68788
- Product ID
- 68788-7591_758c55d3-201f-4d6d-af95-f9dac59b138f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA206296
- Marketing category
- ANDA
- Marketing start
- 2019-05-30
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7591-1 | 68788759101 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7591-1) | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7591-2 | 68788759102 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7591-2) | 2019-11-29 | 0000-00-00 | No | No | Current |
| 68788-7591-3 | 68788759103 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7591-3) | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7591-6 | 68788759106 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7591-6) | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7591-9 | 68788759109 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-7591-9) | 2019-12-27 | 0000-00-00 | No | No | Current |