Dexmethylphenidate Hydrochloride

Product NDC
63629-2173
11-digit product format
636292173
Labeler code
63629
Product ID
63629-2173_6eafcf43-b88e-452f-8946-0136b435a90b
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
20 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
63629-2173-163629217301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2173-1) 2024-08-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dexmethylphenidate HydrochlorideBryant Ranch Prepack2024-08-08HUMAN PRESCRIPTION DRUG LABEL104