METHYLPHENIDATE HYDROCHLORIDE

Product NDC
71335-2968
11-digit product format
713352968
Labeler code
71335
Product ID
71335-2968_d7ed4dad-1fcc-449b-bf11-e839c7b10a56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208737
Marketing category
ANDA
Marketing start
2024-04-16
Substance
METHYLPHENIDATE 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
4B3SC438HIMETHYLPHENIDATE HYDROCHLORIDE23655-65-4METHYLPHENIDATE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2968-171335296801100 TABLET in 1 BOTTLE (71335-2968-1) 100 tablet2025-11-11NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
METHYLPHENIDATE HYDROCHLORIDEBryant Ranch Prepack2025-11-11HUMAN PRESCRIPTION DRUG LABEL100