Omeprazole
- Product NDC
- 55319-219
- 11-digit product format
- 553190219
- Labeler code
- 55319
- Product ID
- 55319-219_5ab86c77-4f33-46e4-84dc-57c96b8fc490
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- ANDA206582
- Marketing category
- ANDA
- Marketing start
- 2025-02-28
- 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 |
|---|
| 55319-219-14 | Omeprazole | 14 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 14 | | 3 |
| 55319-219-14 | Omeprazole | 1 in 1 BOX | TABLET, DELAYED RELEASE | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55319-219 | OMEPRAZOLE TABLET, DELAYED RELEASE [FAMILY DOLLAR (FAMILY WELLNESS)] | 2 | Current NDC, 2 package rows | 20250228_f2195d73-1fd5-4de2-aa5c-18741d11f4fc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-219-14 | 55319021914 | 1 BOTTLE, PLASTIC in 1 BOX (55319-219-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | 2025-02-28 | No | No | Historical |