Omeprazole
- Product NDC
- 50268-657
- 11-digit product format
- 502680657
- Labeler code
- 50268
- Product ID
- 50268-657_2b4a7cc4-60b0-2413-e063-6394a90a4083
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2023-03-22
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| KG60484QX9 | OMEPRAZOLE | 73590-58-6 | OMEPRAZOLE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50268-657-15 | 50268065715 | 50 BLISTER PACK in 1 BOX (50268-657-15) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (50268-657-11) | 50 blister pack | 2023-03-22 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | AvPAK | 2025-01-09 | HUMAN PRESCRIPTION DRUG LABEL | 2 |