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 (Mixed Salts of a Single-Entity Amphetamine Product) EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE (Mixed Salts of a Single-Entity Amphetamine Product) EXTENDED-RELEASE CAPSULES. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, and AMPHETAMINE SULFATE extended-release capsules, for oral use, CII Initial U.S. Approval: 2001

Approved

Approval ID

bcdd2fe2-d0de-4a28-aced-40ac9ce5122d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 7, 2023

Manufacturers

FDA

Burel Pharmaceuticals, LLC

DUNS: 609436204

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code35573-466

Application NumberANDA212037

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateDecember 7, 2023

FDA Product Classification

INGREDIENTS (23)

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816N

Classification: IACT

Methacrylic Acid And Ethyl Acrylate CopolymerInactive

Code: NX76LV5T8J

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JM

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 3.75 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 3.75 mg in 1 1

Code: G83415V073

Classification: ACTIB

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code35573-469

Application NumberANDA212037

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateDecember 7, 2023

FDA Product Classification

INGREDIENTS (23)

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

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816N

Classification: IACT

Methacrylic Acid And Ethyl Acrylate CopolymerInactive

Code: NX76LV5T8J

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JM

Classification: IACT

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 7.5 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 7.5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code35573-467

Application NumberANDA212037

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateDecember 7, 2023

FDA Product Classification

INGREDIENTS (23)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 5.0 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 5.0 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816N

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JM

Classification: IACT

Methacrylic Acid And Ethyl Acrylate CopolymerInactive

Code: NX76LV5T8J

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 5.0 mg in 1 1

Code: G83415V073

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 5.0 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code35573-468

Application NumberANDA212037

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateDecember 7, 2023

FDA Product Classification

INGREDIENTS (22)

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

Methacrylic Acid And Ethyl Acrylate CopolymerInactive

Code: NX76LV5T8J

Classification: IACT

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816N

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

Titanium DioxideInactive

Code: 15FIX9V2JP

Classification: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JM

Classification: IACT

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code35573-465

Application NumberANDA212037

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateDecember 7, 2023

FDA Product Classification

INGREDIENTS (23)

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816N

Classification: IACT

Methacrylic Acid And Ethyl Acrylate CopolymerInactive

Code: NX76LV5T8J

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

Fd&C Yellow No. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JM

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code35573-464

Application NumberANDA212037

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateDecember 7, 2023

FDA Product Classification

INGREDIENTS (24)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

Gelatin, UnspecifiedInactive

Code: 2G86QN327L

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYPROMELLOSE 2910 (50 MPA.S)Inactive

Code: 1IVH67816N

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Methacrylic Acid And Ethyl Acrylate CopolymerInactive

Code: NX76LV5T8J

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

HYPROMELLOSE 2910 (3 MPA.S)Inactive

Code: 0VUT3PMY82

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

Fd&C Red No. 40Inactive

Code: WZB9127XOA

Classification: IACT

ShellacInactive

Code: 46N107B71O

Classification: IACT

Propylene GlycolInactive

Code: 6DC9Q167V3

Classification: IACT

Fd&C Blue No. 1 Aluminum LakeInactive

Code: J9EQA3S2JM

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

Products 6

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (22)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (24)

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