Focalin
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, for oral use, CIIInitial U.S. Approval: 2005
Approved
Approval ID
1a1da905-42a0-4748-9c39-67eca45deccc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 13, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 8
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 Code0078-0434
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 40 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
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 Code0078-0608
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0432
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (7)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
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 Code0078-0430
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0609
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 35 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0433
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0431
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
FDA Product Classification
INGREDIENTS (8)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
DEXMETHYLPHENIDATE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1678OK0E08
Classification: ACTIB
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
dexmethylphenidate hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0493
Application NumberNDA021802
Product Classification
M
Marketing Category
C73594
G
Generic Name
dexmethylphenidate hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 13, 2023
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
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
DEXTROSE, UNSPECIFIED FORMInactive
Code: IY9XDZ35W2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT