Esomeprazole Magnesium
- Product NDC
- 65162-644
- 11-digit product format
- 651620644
- Labeler code
- 65162
- Product ID
- 65162-644_811f5efd-34eb-48b8-87b3-c5c72c1f1507
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole Magnesium
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA209647
- Marketing category
- ANDA
- Marketing start
- 2019-04-10
- 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-644 | ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 11 | Legacy NDC | 20250201_d9c8bc29-9b3b-41bc-a802-02cd85c95a11.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-644-03 | 65162064403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-644-03) | 2019-04-10 | 0000-00-00 | No | No | Current |
| 65162-644-09 | 65162064409 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-644-09) | 2019-04-10 | 0000-00-00 | No | No | Current |
| 65162-644-11 | 65162064411 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-644-11) | 2019-04-10 | 0000-00-00 | No | No | Current |
| 65162-644-50 | 65162064450 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-644-50) | 2019-04-10 | 0000-00-00 | No | No | Current |