Omeprazole
- Product NDC
- 71205-907
- 11-digit product format
- 712050907
- Labeler code
- 71205
- Product ID
- 71205-907_f9c7393f-d347-4ae3-8771-8a3e3615510c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Proficient Rx LP
- 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 |
|---|
| 71205-907-00 | 71205090700 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-00) | 2021-07-19 | No | No | Historical |
| 71205-907-11 | 71205090711 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-11) | 2021-07-19 | No | No | Historical |
| 71205-907-30 | 71205090730 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-30) | 2021-07-19 | No | No | Historical |
| 71205-907-55 | 71205090755 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-55) | 2021-07-19 | No | No | Historical |
| 71205-907-60 | 71205090760 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-60) | 2021-07-19 | No | No | Historical |
| 71205-907-90 | 71205090790 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-907-90) | 2021-07-19 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Proficient Rx LP | 2022-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |