Omeprazole
- Product NDC
- 59726-298
- 11-digit product format
- 597260298
- Labeler code
- 59726
- Product ID
- 59726-298_1ef5cd55-c1c3-40a9-9486-91ad26c24a1c
- 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
- 2025-01-31
- Substance
- OMEPRAZOLE MAGNESIUM
- Active strength
- 20.6 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 | 20.6 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 |
|---|
| 59726-298-14 | Omeprazole | 14 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 14 | | 4 |
| 59726-298-14 | Omeprazole | 1 in 1 BOX | TABLET, DELAYED RELEASE | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59726-298 | OMEPRAZOLE TABLET, DELAYED RELEASE [P & L DEVELOPMENT, LLC] | 3 | Current NDC, 2 package rows | 20250321_44a92926-1941-4fe8-9b2a-31a45289456f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59726-298-14 | 59726029814 | 1 BOTTLE, PLASTIC in 1 BOX (59726-298-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2025-01-31 | No | No | Historical |