Omeprazole
- Product NDC
- 76420-879
- 11-digit product format
- 764200879
- Labeler code
- 76420
- Product ID
- 76420-879_2dfff480-dff9-b242-e063-6394a90a1fcf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA091672
- Marketing category
- ANDA
- Marketing start
- 2014-10-31
- Substance
- OMEPRAZOLE
- Active strength
- 40 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 |
|---|
| 76420-879-00 | 76420087900 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-00) | 2024-12-03 | No | No | Historical |
| 76420-879-01 | 76420087901 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-01) | 2024-12-03 | No | No | Historical |
| 76420-879-03 | 76420087903 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-03) | 2024-12-03 | No | No | Historical |
| 76420-879-06 | 76420087906 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-06) | 2024-12-03 | No | No | Historical |
| 76420-879-09 | 76420087909 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-09) | 2024-12-03 | No | No | Historical |
| 76420-879-12 | 76420087912 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (76420-879-12) | 2025-01-21 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2025-02-13 | HUMAN PRESCRIPTION DRUG LABEL | 6 |