Omeprazole
- Product NDC
- 68788-8864
- 11-digit product format
- 687888864
- Labeler code
- 68788
- Product ID
- 68788-8864_0fb314cb-6291-422c-98ff-24d8449992f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2025-04-23
- 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
openFDA Listing Details
- Product ID
- 68788-8864_0fb314cb-6291-422c-98ff-24d8449992f6
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Omeprazole
- Generic name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing start
- 2025-04-23
- Marketing category
- ANDA
- Application number
- ANDA075757
- Pharmacologic classes
- Cytochrome P450 2C19 Inhibitors [MoA]; Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| OMEPRAZOLE | 20 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 198051 |
| Spl Set Id | 0fb314cb-6291-422c-98ff-24d8449992f6 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
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 |
|---|
| 68788-8864-1 | 68788886401 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-1) | 2025-04-23 | No | No | Current |
| 68788-8864-2 | 68788886402 | 20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-2) | 2025-04-23 | No | No | Current |
| 68788-8864-3 | 68788886403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-3) | 2025-04-23 | No | No | Current |
| 68788-8864-4 | 68788886404 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-4) | 2025-04-23 | No | No | Current |
| 68788-8864-6 | 68788886406 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-6) | 2025-04-23 | No | No | Current |
| 68788-8864-8 | 68788886408 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-8) | 2025-04-23 | No | No | Current |
| 68788-8864-9 | 68788886409 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8864-9) | 2025-04-23 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Preferred Pharmaceuticals Inc. | 2025-04-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |