Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

These highlights do not include all the information needed to use DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES.DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE (mixed salts of a single-entity amphetamine product) extended-release capsules, for oral use, CIIInitial U.S. Approval: 2001

Approved

Approval ID

6438480f-1147-42b6-826d-4e1e1f8ff007

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 10, 2023

Manufacturers

FDA

ANI Pharmaceuticals, Inc.

DUNS: 145588013

Products 6

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

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code43975-277

Application NumberANDA205401

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 31, 2023

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

INGREDIENTS (21)

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

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 1.25 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 1.25 mg in 1 1

Code: G83415V073

Classification: ACTIB

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code43975-279

Application NumberANDA205401

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 31, 2023

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

INGREDIENTS (21)

AMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code43975-280

Application NumberANDA205401

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 31, 2023

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

INGREDIENTS (19)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 5 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code43975-282

Application NumberANDA205401

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 31, 2023

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

INGREDIENTS (19)

AMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code43975-278

Application NumberANDA205401

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 31, 2023

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

INGREDIENTS (21)

AMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code43975-281

Application NumberANDA205401

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateOctober 31, 2023

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

INGREDIENTS (19)

AMPHETAMINE SULFATEActive

Quantity: 6.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 6.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIACETINInactive

Code: XHX3C3X673

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 6.25 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 6.25 mg in 1 1

Code: G83415V073

Classification: ACTIB

AI-Powered Research

Premium Access

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

Products 6

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

INGREDIENTS (21)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

INGREDIENTS (21)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

INGREDIENTS (19)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

INGREDIENTS (19)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

INGREDIENTS (21)

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

INGREDIENTS (19)