FDA.reportPublic FDA data

METHYLPHENIDATE HYDROCHLORIDE

Substance profile for UNII 4B3SC438HI, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for METHYLPHENIDATE HYDROCHLORIDE
Structure render from PubChem CID 154100

Substance Identity#

UNII
4B3SC438HI
Preferred term
METHYLPHENIDATE HYDROCHLORIDE
Registry number
23655-65-4
EC number
206-065-3
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C14H19NO2.ClH
Chemical structure for METHYLPHENIDATE HYDROCHLORIDE
Structure render from PubChem CID 154100

Chemical And Database Identifiers#

SMILES
Cl.COC(=O)[C@@H]([C@H]1CCCCN1)C2=CC=CC=C2
RxCUI
203188
PubChem
154100
NCIt
C646
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound154100pubchem.ncbi.nlm.nih.gov/compound/154100
RxNorm203188mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=203188
NCI ThesaurusC646ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C646
FDA Substance Registration System4B3SC438HIprecision.fda.gov/uniisearch/srs/unii/4B3SC438HI
European Community number206-065-3commonchemistry.cas.org/results?q=206-065-3

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
Methylphenidate Hydrochloride Oral Solution, 5 mg/5 mL CII Methylphenidate Hydrochloride Oral Solution, 10 mg/5 mL CII Rx Only4
Metadate ® ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) CII9
METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP CII9
Ritalin1
These highlights do not include all the information needed to use Methylphenidate HCl Extended-Release Tablets safely and effectively. See full prescribing information for Methylphenidate HCl Extended-Release Tablets. Methylphenidate HCl Extended-Release Tablets CII Initial U.S. Approval: 20001
These highlights do not include all the information needed to use CONCERTA ® safely and effectively. See full prescribing information for CONCERTA ® . CONCERTA ® (methylphenidate HCl) Extended-Release Tablets CII Initial U.S. Approval: 20001
Metadate CD ® (methylphenidate HCl, USP) Extended-Release Capsules CII1
f931d3af-c32a-4406-8799-9b097f41594b2
methylphenidate hydrochloride 10mg Tablet1
330e620f-4b7f-4101-91dd-feddb7a823ed7
d356f9f6-d094-478d-bf79-7781490588cc1
Methylphenidate Hydrochloride Tablets, USP Methylphenidate Hydrochloride Extended-Release Tablets, USP3
METHYLPHENIDATE HYDROCHLORIDE TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3987
METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [MALLINCKRODT, INC.]29
RITALIN LA (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]20
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) TABLET [MALLINCKRODT, INC.]18
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [SHIONOGI INC.]17
METHYLPHENIDATE HYDROCHLORIDE TABLET, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]17
RITALIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET RITALIN SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]16
CONCERTA (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC.]14
METADATE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [UNITHER MANUFACTURING, LLC]13
QUILLIVANT XR (METHYLPHENIDATE HYDROCHLORIDE) POWDER, FOR SUSPENSION [NEXTWAVE PHARMACEUTICALS, INC.]13
METHYLIN (METHYLPHENIDATE HYDROCHLORIDE) TABLET, CHEWABLE [SHIONOGI INC.]12
METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ACTAVIS SOUTH ATLANTIC LLC]12
METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]12
METHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE [MALLINCKRODT, INC.]10
METHYLPHENIDATE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]10
METHYLPHENIDATE HYDROCHLORIDE SOLUTION [TRIS PHARMA INC]8
METHYLPHENIDATE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]8
METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE SR (METHYLPHENIDATE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]8
METHYLPHENIDATE HYDROCHLORIDE TABLET [COREPHARMA, LLC]7
METHYLPHENIDATE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]7
METHYLPHENIDATE HYDROCHLORIDE (CD) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]6
METHYLPHENIDATE HYDROCHLORIDE CD (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]6
APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]5
METHYLPHENIDATE HCL ORAL SOLUTION (METHYLPHENIDATE HYDROCHLORIDE) SOLUTION [MALLINCKRODT, INC.]5
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [AVKARE, INC.]5
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASE TABLET [KVK-TECH, INC.]5
METHYLPHENIDATE HYDROCHLORIDE SOLUTION [CARACO PHARMACEUTICAL LABORATORIES, LTD.]4
METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]3
METHYLPHENIDATE HYDROCHLORIDE SOLUTION [BRECKENRIDGE PHARMACEUTICAL, INC.]3
METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [NOVEL LABORATORIES, INC.]3
METADATE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [UPSTATE PHARMA, LLC]2
METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
METHYLPHENIDATE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]2
METHYLPHENIDATE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
METHYLPHENIDATE HYDROCHLORIDE TABLET [UPSTATE PHARMA, LLC]2
METHYLPHENIDATE HYDROCHLORIDE (CD) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
METHYLPHENIDATE HYDROCHLORIDE TABLET [CAMBER PHARMACEUTICALS INC.]1
METHYLPHENIDATE HYDROCHLORIDE TABLET METHYLPHENIDATE HYDROCHLORIDE ER (METHYLPHENIDATE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]1
METHYLPHENIDATE HYDROCHLORIDE TABLET, CHEWABLE [GAVIS PHARMACEUTICALS, LLC]1