Osmolex ER
- Product NDC
- 68025-077
- 11-digit product format
- 680250077
- Labeler code
- 68025
- Product ID
- 68025-077_50e2fe15-859c-4fa2-8dc6-c0173ebbca31
- 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
- 2018-06-01
- Marketing end
- 0000-00-00
- Substance
- AMANTADINE
- Active strength
- 258 mg/1
- Pharmacologic classes
- Influenza A M2 Protein Inhibitor [EPC],M2 Protein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 68025-077-30 | 68025007730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-077-30) | 2018-06-01 | 0000-00-00 | No | No | Current |
| 68025-077-90 | 68025007790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-077-90) | 2018-06-01 | 0000-00-00 | No | No | Current |