Omeprazole
- Product NDC
- 82804-166
- 11-digit product format
- 828040166
- Labeler code
- 82804
- Product ID
- 82804-166_ee0598a1-0e5e-40ff-ad88-b0adfc533ca0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Substance
- OMEPRAZOLE
- Active strength
- 10 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 |
|---|
| 82804-166-60 | 82804016660 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82804-166-60) | 2024-12-16 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Proficient Rx LP | 2024-12-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |