Yosprala
- Product NDC
- 64950-424
- 11-digit product format
- 649500424
- Labeler code
- 64950
- Product ID
- 64950-424_62779f62-b2fc-40b5-835e-21edf15f24a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aspirin and omeprazole
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Genus Lifesciences Inc.
- Application
- NDA205103
- Marketing category
- NDA
- Marketing start
- 2019-03-04
- Marketing end
- 0000-00-00
- Substance
- ASPIRIN; OMEPRAZOLE
- Active strength
- 81 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], 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 |
|---|
| 64950-424-30 | 64950042430 | 30 TABLET, FILM COATED in 1 BOTTLE (64950-424-30) | 2019-03-04 | 0000-00-00 | No | No | Current |
| 64950-424-90 | 64950042490 | 90 TABLET, FILM COATED in 1 BOTTLE (64950-424-90) | 2019-03-04 | 0000-00-00 | No | No | Current |