Omeprazole
- Product NDC
- 43063-549
- 11-digit product format
- 430630549
- Labeler code
- 43063
- Product ID
- 43063-549_db747126-77d4-2e1d-e053-2a95a90a2d30
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA075576
- Marketing category
- ANDA
- Marketing start
- 2009-01-21
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43063-549-90 | 43063054990 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-549-90) | 2014-11-24 | 0000-00-00 | No | No | Current |