DEXMETHYLPHENIDATE HYDROCHLORIDE

Product NDC
42858-225
11-digit product format
428580225
Labeler code
42858
Product ID
42858-225_0b8b14ae-8e94-409c-a588-66ae49640201
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rhodes Pharmaceuticals L.P.
Application
ANDA208756
Marketing category
ANDA
Marketing start
2017-12-01
Marketing end
0000-00-00
Substance
DEXMETHYLPHENIDATE HYDROCHLORIDE
Active strength
5 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
42858-225-01EA - Each42858-22533b7165e-4fe8-4ea4-a26c-1456012993e112017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-225-0142858022501100 TABLET in 1 BOTTLE (42858-225-01) 100 tablet2017-12-010000-00-00NoNoCurrent