FDA.reportPublic FDA data

DEXMETHYLPHENIDATE HYDROCHLORIDE

Substance profile for UNII 1678OK0E08, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for DEXMETHYLPHENIDATE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Substance Identity#

UNII
1678OK0E08
Preferred term
DEXMETHYLPHENIDATE HYDROCHLORIDE
Registry number
19262-68-1
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C14H19NO2.ClH
Chemical structure for DEXMETHYLPHENIDATE HYDROCHLORIDE
Structure render from NCI/CADD chemical resolver

Chemical And Database Identifiers#

InChIKey
JUMYIBMBTDDLNG-OJERSXHUSA-N
SMILES
Cl.COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2
RxCUI
353105
PubChem
0
NCIt
C47480
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem InChIKey SearchJUMYIBMBTDDLNG-OJERSXHUSA-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=JUMYIBMBTDDLNG-OJERSXHUSA-N
RxNorm353105https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=353105
NCI ThesaurusC47480https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47480
FDA Substance Registration System1678OK0E08https://precision.fda.gov/uniisearch/srs/unii/1678OK0E08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 20051
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 20052
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]36
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]28
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]21
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]15
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]13
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]13
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [SANDOZ INC]11
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]10
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]10
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL INC.]5
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE HYDROCHLORIDE ) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]5
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE (DEXMETHYLPHENIDATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]1
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
DEXMETHYLPHENIDATE HYDROCHLORIDEACTIVE INGREDIENT1678OK0E08DEXMETHYLPHENIDATE HYDROCHLORIDE TABLET [SANDOZ INC]1