Omeprazole delayed release
- Product NDC
- 49483-731
- 11-digit product format
- 494830731
- Labeler code
- 49483
- Product ID
- 49483-731_442e2a90-4ac6-8adf-e063-6394a90a6fc2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole 20mg
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- TIME CAP LABORATORIES, INC.
- Application
- ANDA218829
- Marketing category
- ANDA
- Marketing start
- 2025-12-15
- Substance
- OMEPRAZOLE MAGNESIUM
- 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 |
|---|
| 426QFE7XLK | OMEPRAZOLE MAGNESIUM | 95382-33-5 | OMEPRAZOLE MAGNESIUM |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 49483-731-41 | 49483073141 | 3 BOTTLE in 1 CARTON (49483-731-41) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (49483-731-45) | 3 bottle | 2025-12-15 | No | No | Historical |