Methylphenidate Hydrochloride

Product NDC
63629-2459
11-digit product format
636292459
Labeler code
63629
Product ID
63629-2459_c512f7e5-812d-4066-9345-32976241b19c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205327
Marketing category
ANDA
Marketing start
2017-08-14
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
63629-2459-1EA - Each63629-245926b33d86-0bc7-4afd-8845-2c23be94b18f12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2459METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Legacy NDC20241023_76fe667d-98f5-45ce-ba2a-2739e02b5102.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2459-163629245901100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2459-1) 2021-03-010000-00-00NoNoCurrent