Esomeprazole Magnesium
- Product NDC
- 68071-4536
- 11-digit product format
- 680714536
- Labeler code
- 68071
- Product ID
- 68071-4536_bbb815a8-1b48-3897-e053-2a95a90a6e39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA205606
- Marketing category
- ANDA
- Marketing start
- 2016-04-21
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE
- Active strength
- 20 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 |
|---|
| 68071-4536-1 | 68071453601 | 10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-4536-1) | 2018-08-22 | 0000-00-00 | No | No | Current |
| 68071-4536-6 | 68071453606 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-4536-6) | 2018-08-22 | 0000-00-00 | No | No | Current |