Omeprazole
- Product NDC
- 71610-963
- 11-digit product format
- 716100963
- Labeler code
- 71610
- Product ID
- 71610-963_43091c83-9815-b7df-e063-6394a90aa05b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA212977
- Marketing category
- ANDA
- Marketing start
- 2019-02-20
- 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 |
|---|
| 71610-963-60 | 71610096360 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-60) | 2025-11-07 | No | No | Historical |
| 71610-963-70 | 71610096370 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-70) | 2025-11-07 | No | No | Historical |
| 71610-963-80 | 71610096380 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-963-80) | 2025-11-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Aphena Pharma Solutions - Tennessee, LLC | 2025-11-07 | HUMAN PRESCRIPTION DRUG LABEL | 1 |