Omeprazole
- Product NDC
- 72789-257
- 11-digit product format
- 727890257
- Labeler code
- 72789
- Product ID
- 72789-257_4bac7b98-8e95-1e51-e063-6294a90ab1cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA078490
- Marketing category
- ANDA
- Marketing start
- 2014-03-01
- 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
- 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 | 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 |
|---|
| 72789-257-90 | Omeprazole | 90 in 1 BOTTLE, PLASTIC | CAPSULE, DELAYED RELEASE | 90 | | 34 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72789-257 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.] | 32 | Current NDC, Legacy NDC, 1 package rows | 20240719_0344268f-d8e6-48d5-b1e1-f750ed1d8a52.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 |
|---|
| 72789-257-90 | 72789025790 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-257-90) | 2022-07-05 | 0000-00-00 | No | No | Current |