Ritalin
Ritalin
Approved
Approval ID
cd83fc91-47a3-4be4-9727-caf9ec0371e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-1706
Application NumberNDA010187
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
methylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2762
Application NumberNDA010187
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2012
FDA Product Classification
INGREDIENTS (8)
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRAGACANTHInactive
Code: 2944357O2O
Classification: IACT