Dexmethylphenidate hydrochloride
- Product NDC
- 57664-622
- 11-digit product format
- 576640622
- Labeler code
- 57664
- Product ID
- 57664-622_dfada2f5-18f1-4d93-96ad-7cbca3e712e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA206734
- Marketing category
- ANDA
- Marketing start
- 2021-11-05
- Marketing end
- 0000-00-00
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|
| 57664-622-88 | 57664062288 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (57664-622-88) | 2021-11-05 | 0000-00-00 | No | No | Current |