DEXMETHYLPHENIDATE HYDROCHLORIDE

Product NDC
42858-011
11-digit product format
428580011
Labeler code
42858
Product ID
42858-011_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
3 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
42858-011-01EA - Each42858-011361d444c-76f9-40d1-87c0-dfb00e31483712017-12-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-011-0142858001101100 TABLET in 1 BOTTLE (42858-011-01) 100 tablet2017-12-010000-00-00NoNoCurrent