Omeprazole
- Product NDC
- 42291-572
- 11-digit product format
- 422910572
- Labeler code
- 42291
- Product ID
- 42291-572_d57db043-b83f-37b3-e053-2a95a90a9a02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Omeprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA076048
- Marketing category
- ANDA
- Marketing start
- 2018-05-08
- Marketing end
- 0000-00-00
- Substance
- OMEPRAZOLE
- Active strength
- 20 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 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 |
|---|
| 42291-572-10 | 42291057210 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42291-572-10) | 2018-05-08 | 0000-00-00 | No | No | Current |