METHYLPHENIDATE HYDROCHLORIDE

Product NDC
47781-629
11-digit product format
477810629
Labeler code
47781
Product ID
47781-629_a86a9b60-8a61-9c19-def0-33f7609ada1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA204772
Marketing category
ANDA
Marketing start
2019-02-22
Marketing end
2023-12-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-629-01EA - Each47781-62985099b6b-a1ea-41e7-a98e-7bb1b2063eae12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-629-0147781062901100 TABLET, EXTENDED RELEASE in 1 PACKAGE (47781-629-01) 2019-03-200000-00-00NoNoCurrent