Dexmethylphenidate Hydrochloride
These highlights do not include all the information needed to use DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS. DEXMETHYLPHENIDATE tablets, for oral use, CII Initial U.S. Approval: 2001
Approved
Approval ID
779ece39-b6fa-4977-8df5-d018d39d4d0d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2023
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dexmethylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1899
Application NumberANDA209468
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexmethylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Dexmethylphenidate Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1900
Application NumberANDA209468
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dexmethylphenidate Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (7)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-1901
Application NumberANDA209468
Product Classification
M
Marketing Category
C73584
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 27, 2023
FDA Product Classification
INGREDIENTS (6)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT