OMEPRAZOLE
- Product NDC
- 61919-847
- 11-digit product format
- 619190847
- Labeler code
- 61919
- Product ID
- 61919-847_c1c31f1c-23b7-6193-e053-2995a90abc73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- OMEPRAZOLE
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Direct Rx
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2020-08-12
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| KG60484QX9 | OMEPRAZOLE | 73590-58-6 | OMEPRAZOLE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61919-847-30 | 61919084730 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-847-30) | 2020-08-12 | 0000-00-00 | No | No | Current |
| 61919-847-60 | 61919084760 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-847-60) | 2020-08-12 | 0000-00-00 | No | No | Current |
| 61919-847-90 | 61919084790 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-847-90) | 2020-08-12 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| OMEPRAZOLE DR | Direct Rx | 2023-05-31 | HUMAN PRESCRIPTION DRUG LABEL | 14 |