METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride Tablets, USP These highlights do not include all the information needed to use METHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHYLPHENIDATE HYDROCHLORIDE TABLETS. Initial U.S. Approval: 1955
Approved
Approval ID
9e7967c8-d323-160d-e053-2995a90a323e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
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 Code50268-528
Application NumberANDA207416
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPHENIDATE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (6)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-529
Application NumberANDA207416
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPHENIDATE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (7)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT