Omeprazole
- Product NDC
- 71610-248
- 11-digit product format
- 716100248
- Labeler code
- 71610
- Product ID
- 71610-248_b9ce8938-5ddf-4556-84d0-c3d2eb64a734
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-248-60 | 71610024860 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-248-60) | 2019-03-13 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Aphena Pharma Solutions - Tennessee, LLC | 2019-03-20 | HUMAN PRESCRIPTION DRUG LABEL | 1 |