Omeprazole
- Product NDC
- 59726-744
- 11-digit product format
- 597260744
- Labeler code
- 59726
- Product ID
- 59726-744_d8e96cde-13b1-4f97-8e0d-4a60f28e270e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- P & L Development, LLC
- Application
- ANDA206582
- Marketing category
- ANDA
- Marketing start
- 2025-08-29
- 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
- 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 |
|---|
| 59726-744-42 | Omeprazole | 3 in 1 BOX | TABLET, DELAYED RELEASE | 3 | | 2 |
| 59726-744-42 | Omeprazole | 14 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 14 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59726-744-42 | 59726074442 | 3 BOTTLE, PLASTIC in 1 BOX (59726-744-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2025-08-29 | No | No | Historical |