ESOMEPRAZOLE MAGNESIUM
- Product NDC
- 76519-1173
- 11-digit product format
- 765191173
- Labeler code
- 76519
- Product ID
- 76519-1173_9ab66178-9c73-65ef-e053-2995a90aee2d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA078279
- Marketing category
- ANDA
- Marketing start
- 2019-03-25
- Marketing end
- 0000-00-00
- Substance
- ESOMEPRAZOLE MAGNESIUM
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R6DXU4WAY9 | ESOMEPRAZOLE MAGNESIUM | 217087-09-7 | ESOMEPRAZOLE MAGNESIUM |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76519-1173-3 | 76519117303 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76519-1173-3) | 2019-03-25 | 0000-00-00 | No | No | Current |