Omeprazole
- Product NDC
- 68071-4025
- 11-digit product format
- 680714025
- Labeler code
- 68071
- Product ID
- 68071-4025_1d7a3d9e-4559-eb2e-e063-6294a90a8f78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2002-11-04
- 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
- 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KG60484QX9 |
| Rxcui | 198051 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4025-3 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4025 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240817_55a1fb3c-f040-2e39-e054-00144ff8d46c.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 |
|---|
| 68071-4025-3 | 68071402503 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-4025-3) | 2017-07-31 | 0000-00-00 | No | No | Current |