Omeprazole
- Product NDC
- 50436-8158
- 11-digit product format
- 504368158
- Labeler code
- 50436
- Product ID
- 50436-8158_b512da3f-010d-4c1e-a041-8dae20fc87ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- 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
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 |
|---|
| 50436-8158-1 | 50436815801 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-8158-1) | 2021-09-17 | 0000-00-00 | No | No | Current |
| 50436-8158-2 | 50436815802 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50436-8158-2) | 2021-09-17 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Unit Dose Services | 2021-09-17 | HUMAN PRESCRIPTION DRUG LABEL | 7 |