Omeprazole
- Product NDC
- 71610-876
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA078490
- Marketing category
- ANDA
- Substance
- OMEPRAZOLE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 71610-876-53 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-53) | 2025-02-06 | | No | Historical |
| 71610-876-60 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-60) | 2025-02-06 | | No | Historical |
| 71610-876-70 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-70) | 2025-02-06 | | No | Historical |
| 71610-876-80 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-876-80) | 2025-02-06 | | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Aphena Pharma Solutions - Tennessee, LLC | 2025-02-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |