Omeprazole
- Product NDC
- 50090-5901
- 11-digit product format
- 500905901
- Labeler code
- 50090
- Product ID
- 50090-5901_83204a11-3cda-4a40-96f7-5dc3907310e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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 |
|---|
| 50090-5901-0 | 50090590100 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-0) | 2022-01-13 | No | No | Historical |
| 50090-5901-2 | 50090590102 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-2) | 2022-01-21 | No | No | Historical |
| 50090-5901-3 | 50090590103 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-3) | 2022-01-21 | No | No | Historical |
| 50090-5901-5 | 50090590105 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-5) | 2022-01-21 | No | No | Historical |
| 50090-5901-6 | 50090590106 | 200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5901-6) | 2022-01-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | A-S Medication Solutions | 2025-10-10 | HUMAN PRESCRIPTION DRUG LABEL | 5 |
| Omeprazole | A-S Medication Solutions | 2024-01-02 | HUMAN PRESCRIPTION DRUG LABEL | 3 |