Focalin

Products8

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Focalin XR

Product Details

NDC Product Code

0078-0434

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 40 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

Focalin XR

Product Details

NDC Product Code

0078-0608

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 25 mg in 1 1

Focalin XR

Product Details

NDC Product Code

0078-0432

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 20 mg in 1 1

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

Focalin XR

Product Details

NDC Product Code

0078-0430

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 5 mg in 1 1

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Focalin XR

Product Details

NDC Product Code

0078-0609

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 35 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

Focalin XR

Product Details

NDC Product Code

0078-0433

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 30 mg in 1 1

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

Focalin XR

Product Details

NDC Product Code

0078-0431

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 10 mg in 1 1

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Focalin XR

Product Details

NDC Product Code

0078-0493

Application Number

NDA021802

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 13, 2023

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 15 mg in 1 1

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

DEXTROSE, UNSPECIFIED FORMInactive

Code: IY9XDZ35W2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

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Products8

Focalin XR

Product Details

Focalin XR

Product Details

Focalin XR

Product Details

Focalin XR

Product Details

Focalin XR

Product Details

Focalin XR

Product Details

Focalin XR

Product Details

Focalin XR

Product Details