Methylphenidate hydrochloride

Product NDC
47781-418
11-digit product format
477810418
Labeler code
47781
Product ID
47781-418_b32ff40d-bd27-9c66-4627-63e7832934aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methylphenidate hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA210818
Marketing category
ANDA
Marketing start
2018-11-30
Marketing end
2022-11-01
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
54 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
47781-418-01EA - Each47781-4185c4f5417-4f21-46ff-b4b1-2dd6f08ced5f12019-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47781-418-0147781041801100 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-418-01) 2019-01-092022-11-01NoNoCurrent