Methylphenidate Hydrochloride

Product NDC
63629-1919
11-digit product format
636291919
Labeler code
63629
Product ID
63629-1919_6c388226-4bf4-4a6c-b432-97b9ac3b43e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210354
Marketing category
ANDA
Marketing start
2018-03-01
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 formatDescriptionMarketing startSampleExclude flagStatus
63629-1919-163629191901100 TABLET, CHEWABLE in 1 BOTTLE (63629-1919-1) 2021-12-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Methylphenidate Hydrochloride Chewable Tablets CII 2.5 mg, 5 mg and 10 mg Rx onlyBryant Ranch Prepack2024-01-09HUMAN PRESCRIPTION DRUG LABEL103