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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-385
Application NumberNDA021303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-389
Application NumberNDA021303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-383
Application NumberNDA021303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-391
Application NumberNDA021303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-387
Application NumberNDA021303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54092-381
Application NumberNDA021303
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate and Amphetamine Aspartate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2023
FDA Product Classification
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