Methylphenidate Hydrochloride
These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for . Initial U.S. Approval: 1955
Approved
Approval ID
e817377f-bc72-415a-acd2-7136746b2479
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
FDA
Cranbury Pharmaceuticals, LLC
DUNS: 120378264
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylphenidate Hydrochloride
PRODUCT DETAILS
NDC Product Code27808-058
Application NumberANDA091601
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 26, 2021
Generic NameMethylphenidate Hydrochloride
INGREDIENTS (6)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: 4B3SC438HI
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
Methylphenidate Hydrochloride
PRODUCT DETAILS
NDC Product Code27808-059
Application NumberANDA091601
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 26, 2021
Generic NameMethylphenidate Hydrochloride
INGREDIENTS (6)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 5 mL
Code: 4B3SC438HI
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT