Esomeprazole sodium
- Product NDC
- 67457-392
- 11-digit product format
- 674570392
- Labeler code
- 67457
- Product ID
- 67457-392_3b8d6e09-a4d6-49b7-a32a-101ddd739974
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Esomeprazole sodium
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA202686
- Marketing category
- ANDA
- Marketing start
- 2018-06-01
- Marketing end
- 2022-03-31
- Substance
- ESOMEPRAZOLE SODIUM
- Active strength
- 40 mg/5mL
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-392-99 | 67457039299 | 10 VIAL in 1 CARTON (67457-392-99) > 5 mL in 1 VIAL | 10 vial | 2018-06-01 | 2022-03-31 | No | No | Current |