Omeprazole
- Product NDC
- 67046-1509
- 11-digit product format
- 670461509
- Labeler code
- 67046
- Product ID
- 67046-1509_2cdc3fb1-fe88-d5eb-e063-6394a90a439a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2025-01-29
- Substance
- OMEPRAZOLE
- 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
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1509-3 | 67046150903 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-1509-3) | 2025-01-29 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Coupler LLC | 2025-01-29 | HUMAN PRESCRIPTION DRUG LABEL | 1 |