Omeprazole
- Product NDC
- 53217-353
- 11-digit product format
- 532170353
- Labeler code
- 53217
- Product ID
- 53217-353_a5f64e1a-f47d-483a-8b82-56998bd652fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA075410
- Marketing category
- ANDA
- Marketing start
- 2018-01-18
- 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
- 2019-12-31
- 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 |
|---|
| 53217-353-30 | Omeprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-353 | OMEPRAZOLE CAPSULE, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20180820_f03f6191-45cd-4c20-8bd5-783cb28d26c8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-353-30 | 53217035330 | 30 in 1 BOTTLE | Historical |