Esomeprazole magnesium
- Product NDC
- 71610-665
- 11-digit product format
- 716100665
- Labeler code
- 71610
- Product ID
- 71610-665_1364b6a6-b1c3-49db-80ba-45e060cb4cf5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA209735
- Marketing category
- ANDA
- Marketing start
- 2018-05-31
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM
- Active strength
- 40 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 |
|---|
| 71610-665 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC | 20221013_59502415-e290-45b8-b96c-ea7c2a601ab4.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71610-665-30 | 71610066530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-30) | 2022-10-05 | 0000-00-00 | No | No | Current |
| 71610-665-53 | 71610066553 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-53) | 2022-10-05 | 0000-00-00 | No | No | Current |
| 71610-665-60 | 71610066560 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-60) | 2022-10-05 | 0000-00-00 | No | No | Current |
| 71610-665-80 | 71610066580 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-665-80) | 2022-10-05 | 0000-00-00 | No | No | Current |