Omeprazole
- Product NDC
- 53002-2688
- 11-digit product format
- 530022688
- Labeler code
- 53002
- Product ID
- 53002-2688_f1c12636-1407-45d4-854d-f4123ed29fbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2009-01-23
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 40 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|
| 53002-2688-0 | Omeprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 3 |
| 53002-2688-3 | 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 |
|---|
| 53002-2688 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20230609_1ba0fa57-b5a5-4e6a-9902-654d3aefc71f.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 |
|---|
| 53002-2688-0 | 53002268800 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-2688-0) | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-2688-3 | 53002268803 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (53002-2688-3) | 2019-01-01 | 0000-00-00 | No | No | Current |