Methylphenidate Hydrochloride

Product NDC
63629-2460
11-digit product format
636292460
Labeler code
63629
Product ID
63629-2460_bc0e8380-304a-4916-8010-1a4304d1f41b
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
27 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
63629-2460-1EA - Each63629-2460f3fa6835-54ad-4b93-a2fc-3781ca6ad1d412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2460METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]104Legacy NDC20241023_af3a11ff-8b24-4b48-bcd0-1faff1535985.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2460-163629246001100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-2460-1) 2021-03-010000-00-00NoNoCurrent