topcare omeprazole
- Product NDC
- 76162-470
- 11-digit product format
- 761620470
- Labeler code
- 76162
- Product ID
- 76162-470_255def35-0ba3-44c0-af0c-e5aa99806996
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- NDA022032
- Marketing category
- NDA
- Marketing start
- 2022-09-22
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-470-01 | 76162047001 | 1 BOTTLE in 1 CARTON (76162-470-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2022-09-22 | No | No | Historical |
| 76162-470-03 | 76162047003 | 3 BOTTLE in 1 CARTON (76162-470-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2022-09-22 | No | No | Historical |