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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Omeprazole delayed release
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE MAGNESIUM | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 426QFE7XLK |
| Rxcui | 402014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49483-731-41 | Omeprazole delayed release | 3 in 1 CARTON | TABLET, DELAYED RELEASE | 3 | | 2 |
| 49483-731-45 | Omeprazole delayed release | 14 in 1 BOTTLE | TABLET, DELAYED RELEASE | 14 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |
| 49483-731-45 | 49483073145 | 14 in 1 BOTTLE | | | | | Historical |