Dexmethylphenidate Hydrochloride

Product NDC
72162-1473
11-digit product format
721621473
Labeler code
72162
Product ID
72162-1473_4a7ad9cd-cf63-4cd3-b6d3-42703d9f9e00
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
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE19262-68-1DEXMETHYLPHENIDATE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1473-172162147301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1473-1) 2024-08-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dexmethylphenidate HydrochlorideBryant Ranch Prepack2024-08-12HUMAN PRESCRIPTION DRUG LABEL102