Omeprazole
- Product NDC
- 70700-151
- 11-digit product format
- 707000151
- Labeler code
- 70700
- Product ID
- 70700-151_49528611-b139-6768-e43e-bc6f26715fa3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Xiromed, LLC
- Application
- ANDA212977
- Marketing category
- ANDA
- Marketing start
- 2025-01-30
- 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
- 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 | 198051, 199119, 200329 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70700-151-00 | Omeprazole | 1 in 1 PAIL | CAPSULE, DELAYED RELEASE | 1 | | 20 |
| 70700-151-10 | Omeprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 20 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70700-151 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [XIROMED, LLC] | 20 | Current NDC, 2 package rows | 20250201_38bd8e13-591e-f11b-7d8a-11717c56493c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70700-151-00 | 70700015100 | 1 CAPSULE, DELAYED RELEASE in 1 PAIL (70700-151-00) | 2025-01-30 | No | No | Current |
| 70700-151-10 | 70700015110 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-151-10) | 2025-01-30 | No | No | Current |