Omeprazole
- Product NDC
- 68071-2655
- 11-digit product format
- 680712655
- Labeler code
- 68071
- Product ID
- 68071-2655_da481c98-3cfe-1c05-e053-2995a90a8a35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075757
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-2655-1 | 68071265501 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-1) | 2022-03-15 | 0000-00-00 | No | No | Current |
| 68071-2655-3 | 68071265503 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-3) | 2022-03-15 | 0000-00-00 | No | No | Current |
| 68071-2655-4 | 68071265504 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-4) | 2022-03-15 | 0000-00-00 | No | No | Current |
| 68071-2655-6 | 68071265506 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-6) | 2022-03-15 | 0000-00-00 | No | No | Current |
| 68071-2655-7 | 68071265507 | 7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-7) | 2022-03-15 | 0000-00-00 | No | No | Current |
| 68071-2655-8 | 68071265508 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-8) | 2022-03-15 | 0000-00-00 | No | No | Current |
| 68071-2655-9 | 68071265509 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2655-9) | 2022-03-15 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | NuCare Pharmaceuticals,Inc. | 2023-04-17 | HUMAN PRESCRIPTION DRUG LABEL | 2 |