METHYLPHENIDATE HYDROCHLORIDE

Product NDC
72162-2019
11-digit product format
721622019
Labeler code
72162
Product ID
72162-2019_13a17c5a-bba7-4c5a-a4f9-2141bcdffa1a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091159
Marketing category
ANDA
Marketing start
2014-04-07
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
5 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
4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE23655-65-4METHYLPHENIDATE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2019-172162201901100 TABLET in 1 BOTTLE (72162-2019-1) 100 tablet2024-04-03NoNoHistorical
72162-2019-67216220190660 TABLET in 1 BOTTLE (72162-2019-6) 60 tablet2024-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack2024-04-03HUMAN PRESCRIPTION DRUG LABEL102