Esomeprazole Magnesium
- Product NDC
- 68788-8160
- 11-digit product format
- 687888160
- Labeler code
- 68788
- Product ID
- 68788-8160_d47c8c14-d4a1-4351-936a-9a0af3bd3740
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA211977
- Marketing category
- ANDA
- Marketing start
- 2022-04-01
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-8160-1 | 68788816001 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8160-1) | 2022-04-01 | 0000-00-00 | No | No | Current |
| 68788-8160-2 | 68788816002 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8160-2) | 2022-04-01 | 0000-00-00 | No | No | Current |
| 68788-8160-3 | 68788816003 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8160-3) | 2022-04-01 | 0000-00-00 | No | No | Current |
| 68788-8160-6 | 68788816006 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8160-6) | 2022-04-01 | 0000-00-00 | No | No | Current |
| 68788-8160-9 | 68788816009 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8160-9) | 2022-04-01 | 0000-00-00 | No | No | Current |