FocalinXR
These highlights do not include all the information needed to use FOCALIN XR safely and effectively. See full prescribing information for FOCALIN XR. FOCALIN XR (dexmethylphenidate hydrochloride) Extended-Release Capsules CII for oral use Initial U.S. Approval: 2005
Approved
Approval ID
00f1d83e-93cc-4bbe-9c3b-c488062271ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 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.
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5682
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2011
FDA Product Classification
INGREDIENTS (8)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5681
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2011
FDA Product Classification
INGREDIENTS (8)
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5684
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2011
FDA Product Classification
INGREDIENTS (7)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5683
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 11, 2011
FDA Product Classification
INGREDIENTS (9)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT