Metadate CD
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules CII
Approved
Approval ID
be6f8d00-9281-4f67-b8fc-3de58a4d14f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 4
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 Code54868-6234
Application NumberNDA021259
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2011
FDA Product Classification
INGREDIENTS (10)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
methylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5397
Application NumberNDA021259
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2011
FDA Product Classification
INGREDIENTS (10)
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
methylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0668
Application NumberNDA021259
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2011
FDA Product Classification
INGREDIENTS (10)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
methylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4718
Application NumberNDA021259
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 3, 2011
FDA Product Classification
INGREDIENTS (9)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
METHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 4B3SC438HI
Classification: ACTIB
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT