omeprazole
- Product NDC
- 42507-164
- 11-digit product format
- 425070164
- Labeler code
- 42507
- Product ID
- 42507-164_c1ec28a1-d0e5-4878-8295-eb06ff5e1fd6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- NDA209400
- Marketing category
- NDA
- Marketing start
- 2026-01-28
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- omeprazole
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 2003656 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-164-42 | omeprazole | 14 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 14 | | 2 |
| 42507-164-42 | omeprazole | 3 in 1 CARTON | TABLET, ORALLY DISINTEGRATING, D | 3 | | 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 |
|---|
| 42507-164-42 | 42507016442 | 3 CARTON in 1 CARTON (42507-164-42) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK | 3 carton | 2026-01-28 | No | No | Current |