Mixed Salts of a Single Entity Amphetamine Product

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

Approved

Approval ID

60a2834c-38a2-480e-b89c-563e9cf0c9c3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 29, 2023

Manufacturers

FDA

SpecGx LLC

DUNS: 080679498

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, Amphetamine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-8953

Application NumberANDA211547

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (21)

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

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROUS OXIDEInactive

Code: G7036X8B5H

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

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, Amphetamine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-8952

Application NumberANDA211547

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (21)

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

SUCROSEInactive

Code: C151H8M554

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERROUS OXIDEInactive

Code: G7036X8B5H

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

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, Amphetamine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-8956

Application NumberANDA211547

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (21)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERROUS OXIDEInactive

Code: G7036X8B5H

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

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, Amphetamine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-8955

Application NumberANDA211547

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (21)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 6.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROUS OXIDEInactive

Code: G7036X8B5H

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 6.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

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

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-8954

Application NumberANDA211547

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (21)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROUS OXIDEInactive

Code: G7036X8B5H

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-8951

Application NumberANDA211547

Product Classification

Marketing Category

C73584

Generic Name

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

Product Specifications

Route of AdministrationORAL

Effective DateNovember 29, 2023

FDA Product Classification

INGREDIENTS (23)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 9XZ8H6N6OH

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERROUS OXIDEInactive

Code: G7036X8B5H

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

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

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Mixed Salts of a Single Entity Amphetamine Product

Products 6

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (21)

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

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (23)

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