Adderall

These highlights do not include all the information needed to use ADDERALL XR safely and effectively. See full prescribing information for ADDERALL XR. ADDERALL XR (mixed salts of a single-entity amphetamine product) extended-release capsules, for oral use, CII Initial U.S. Approval: 2001

Approved

Approval ID

aff45863-ffe1-4d4f-8acf-c7081512a6c0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 25, 2023

Manufacturers

FDA

Takeda Pharmaceuticals America, Inc.

DUNS: 039997266

Products 6

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

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

NDC Product Code54092-385

Application NumberNDA021303

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 25, 2023

Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

INGREDIENTS (12)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 3.75 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 3.75 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

NDC Product Code54092-389

Application NumberNDA021303

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 25, 2023

Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

INGREDIENTS (13)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 6.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 6.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 6.25 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 6.25 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

NDC Product Code54092-383

Application NumberNDA021303

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 25, 2023

Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

INGREDIENTS (12)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 2.5 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 2.5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

NDC Product Code54092-391

Application NumberNDA021303

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 25, 2023

Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

INGREDIENTS (13)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 7.5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 7.5 mg in 1 1

Code: G83415V073

Classification: ACTIB

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

NDC Product Code54092-387

Application NumberNDA021303

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 25, 2023

Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

INGREDIENTS (13)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 5 mg in 1 1

Code: G83415V073

Classification: ACTIB

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

NDC Product Code54092-381

Application NumberNDA021303

Marketing CategoryC73594

Route of AdministrationORAL

Effective DateOctober 25, 2023

Generic NameDextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

INGREDIENTS (12)

AMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 1.25 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 1.25 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

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Adderall

Products 6

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

INGREDIENTS (12)

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

INGREDIENTS (13)

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

INGREDIENTS (12)

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

INGREDIENTS (13)

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

INGREDIENTS (13)

Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate

PRODUCT DETAILS

INGREDIENTS (12)