Methylphenidate Hydrochloride

Product NDC
63629-1176
11-digit product format
636291176
Labeler code
63629
Product ID
63629-1176_766addd2-4d8e-4ce0-b09b-746632c16ac6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210139
Marketing category
ANDA
Marketing start
2019-03-29
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
10 mg/5mL
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
63629-1176-163629117601500 mL in 1 BOTTLE (63629-1176-1) 500 ml2021-06-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Methylphenidate HydrochlorideBryant Ranch Prepack2024-01-10HUMAN PRESCRIPTION DRUG LABEL6