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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-058
Application NumberANDA091601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2021
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-059
Application NumberANDA091601
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 26, 2021
FDA Product Classification
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