Dexmethylphenidate Hydrochloride

Product NDC
72162-1502
11-digit product format
721621502
Labeler code
72162
Product ID
72162-1502_51f04bf3-77fc-4f1a-a024-ef3d7ede8955
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dexmethylphenidate Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078992
Marketing category
ANDA
Marketing start
2013-11-19
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
15 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
72162-1502-172162150201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1502-1) 2013-11-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dexmethylphenidate Hydrochloride Extended-ReleaseBryant Ranch Prepack2024-05-30HUMAN PRESCRIPTION DRUG LABEL104