DYANAVEL XR
- Product NDC
- 27808-106
- 11-digit product format
- 278080106
- Labeler code
- 27808
- Product ID
- 27808-106_c92bfc3d-e9d4-42d2-ae4e-1590d5610f52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amphetamine
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Tris Pharma Inc
- Application
- NDA210526
- Marketing category
- NDA
- Marketing start
- 2021-11-04
- Marketing end
- 0000-00-00
- Substance
- AMPHETAMINE
- Active strength
- 5 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- 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 |
|---|
| 27808-106-01 | 27808010601 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (27808-106-01) | 2022-02-28 | 0000-00-00 | No | No | Current |