Dexmethylphenidate Hydrochloride

Product NDC
63629-2307
11-digit product format
636292307
Labeler code
63629
Product ID
63629-2307_e3e20e09-b76f-487f-802e-dd26ccdd753d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dexmethylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207901
Marketing category
ANDA
Marketing start
2001-11-30
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-2307-163629230701100 TABLET in 1 BOTTLE, PLASTIC (63629-2307-1) 100 tablet2021-12-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dexmethylphenidate HydrochlorideBryant Ranch Prepack2024-01-10HUMAN PRESCRIPTION DRUG LABEL103