Methylphenidate Hydrochloride

Product NDC
0603-4578
11-digit product format
006034578
Labeler code
0603
Product ID
0603-4578_b7b2667b-3380-44f5-98eb-a1561fb1c80c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methylphenidate hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA202892
Marketing category
ANDA
Marketing start
2014-09-23
Marketing end
2021-04-30
Substance
METHYLPHENIDATE HYDROCHLORIDE
Active strength
20 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
0603-4578-21EA - Each0603-457890f4523f-6e94-42ad-8abc-0f2de1c0cd6f12014-11-05
0603-4578-32EA - Each0603-4578af303b46-0ac0-4e93-8fbd-2efec62be29112014-11-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-4578-2100603457821100 TABLET in 1 BOTTLE, PLASTIC (0603-4578-21) 100 tablet2014-09-232021-04-30NoNoCurrent