Methylphenidate Hydrochloride

Product NDC
63629-2461
11-digit product format
636292461
Labeler code
63629
Product ID
63629-2461_d55cbcb7-9a38-4ccf-98cb-e90bf0d5c9ee
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
36 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
63629-2461-1EA - Each63629-2461c232d613-99cf-4414-9eb8-76744db43fbf12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2461METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Legacy NDC20241023_a7f8225b-ad17-43b2-abc4-e0d340a22562.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2461-163629246101100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2461-1) 2022-02-080000-00-00NoNoCurrent