Dexmethylphenidate Hydrochloride
- Product NDC
- 63629-2178
- 11-digit product format
- 636292178
- Labeler code
- 63629
- Product ID
- 63629-2178_b056b03d-9115-444c-9bbd-20f3ca7f1608
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202842
- Marketing category
- ANDA
- Marketing start
- 2017-01-05
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 1678OK0E08 | DEXMETHYLPHENIDATE HYDROCHLORIDE | 19262-68-1 | DEXMETHYLPHENIDATE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63629-2178-1 | 63629217801 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2178-1) | 2024-08-08 | No | No | Historical |