Methylin
These highlights do not include all the information needed to use METHYLIN s afely and effectively. See full prescribing information for METHYLIN . METHYLIN (methylphenidate hydrochloride) oral solution, CII Initial U.S. Approval: 1955
Approved
Approval ID
9e3c22d9-71d9-46a7-b315-8021c94c4bec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
SHIONOGI INC.
DUNS: 098241610
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-755
Application NumberNDA021419
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (5)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 5 mL
Code: 4B3SC438HI
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Methylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59630-750
Application NumberNDA021419
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2023
FDA Product Classification
INGREDIENTS (5)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 5 mL
Code: 4B3SC438HI
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 1450Inactive
Code: OJ4Z5Z32L4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT