Osmolex ER
- Product NDC
- 68025-021
- 11-digit product format
- 680250021
- Labeler code
- 68025
- Product ID
- 68025-021_ce2e1a99-33cb-84e4-e053-2a95a90a71e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amantadine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Vertical Pharmaceuticals, LLC
- Application
- NDA209410
- Marketing category
- NDA
- Marketing start
- 2022-05-05
- Marketing end
- 2023-06-30
- Substance
- AMANTADINE
- Active strength
- 161 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC], M2 Protein 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 | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68025-021-30 | 68025002130 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-021-30) | 2022-05-05 | 2023-06-30 | No | No | Current |
| 68025-021-90 | 68025002190 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-021-90) | 2022-05-05 | 2023-06-30 | No | No | Current |