esomeprazole magnesium
- Product NDC
- 68071-5117
- 11-digit product format
- 680715117
- Labeler code
- 68071
- Product ID
- 68071-5117_bbf504da-d71d-5632-e053-2995a90affe9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare 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
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-5117-9 | 68071511709 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5117-9) | 2019-11-21 | 0000-00-00 | No | No | Current |