Methylphenidate Hydrochloride

Product NDC
63629-1231
11-digit product format
636291231
Labeler code
63629
Product ID
63629-1231_4ddda3b3-e402-410b-8bf9-75d6d16a07b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate Hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211009
Marketing category
ANDA
Marketing start
2019-09-03
Marketing end
0000-00-00
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
18 mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1231-1EA - Each63629-1231bfa9533b-084f-432f-8331-cf1fd7ea609f12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-1231-163629123101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1231-1) 2021-12-210000-00-00NoNoCurrent