Omeprazole
- Product NDC
- 80425-0109
- 11-digit product format
- 804250109
- Labeler code
- 80425
- Product ID
- 80425-0109_2a999573-1030-813a-e063-6294a90a49b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2019-10-25
- Substance
- OMEPRAZOLE
- Active strength
- 40 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
- Brand name suffix
- DR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMEPRAZOLE | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 200329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0109-1 | OmeprazoleDR | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0109 | OMEPRAZOLE DR (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250101_b4cd8ed1-d9d3-5b57-e053-2995a90a9f3c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 80425-0109-1 | 80425010901 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0109-1) | 2019-10-25 | 0000-00-00 | No | No | Current |