Omeprazole
- Product NDC
- 71205-613
- 11-digit product format
- 712050613
- Labeler code
- 71205
- Product ID
- 71205-613_d870bdc1-5e26-4153-89e2-f629fef60ad0
- 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 |
|---|
| 71205-613-06 | 71205061306 | 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-06) | 2023-08-14 | No | No | Historical |
| 71205-613-14 | 71205061314 | 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-14) | 2022-03-07 | No | No | Historical |
| 71205-613-30 | 71205061330 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-30) | 2021-10-25 | No | No | Historical |
| 71205-613-60 | 71205061360 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-60) | 2021-10-25 | No | No | Historical |
| 71205-613-90 | 71205061390 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-613-90) | 2021-10-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Omeprazole | Proficient Rx LP | 2023-08-01 | HUMAN PRESCRIPTION DRUG LABEL | 4 |