Dexmethylphenidate hydrochloride
- Product NDC
- 16714-568
- 11-digit product format
- 167140568
- Labeler code
- 16714
- Product ID
- 16714-568_2885e800-bd09-4031-b069-8bb153e15b98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Northstar Rx LLC
- Application
- ANDA206734
- Marketing category
- ANDA
- Marketing start
- 2022-01-21
- Marketing end
- 0000-00-00
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 35 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
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-568 | DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NORTHSTAR RX LLC] | 3 | Legacy NDC | 20250114_b58a3015-fbf3-4ad7-a9f4-3a9cbc3e4258.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16714-568-01 | 16714056801 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-568-01) | 2022-01-21 | 0000-00-00 | No | No | Current |