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

d91c8624-8002-4f03-ad26-deb195be4e09

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2021

Manufacturers

FDA

Ascent Pharmaceuticals, Inc

DUNS: 080938961

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 Code43602-318

Application NumberANDA214959

Product Classification

Marketing Category

C73584

Generic Name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2021

FDA Product Classification

INGREDIENTS (26)

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

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZ

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-319

Application NumberANDA214959

Product Classification

Marketing Category

C73584

Generic Name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2021

FDA Product Classification

INGREDIENTS (28)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZ

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

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 and amphetamine sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-320

Application NumberANDA214959

Product Classification

Marketing Category

C73584

Generic Name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2021

FDA Product Classification

INGREDIENTS (26)

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

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZ

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

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 and amphetamine sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-316

Application NumberANDA214959

Product Classification

Marketing Category

C73584

Generic Name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2021

FDA Product Classification

INGREDIENTS (26)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

AMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code43602-321

Application NumberANDA214959

Product Classification

Marketing Category

C73584

Generic Name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2021

FDA Product Classification

INGREDIENTS (26)

AMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZ

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

GELATINInactive

Code: 2G86QN327L

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 Code43602-317

Application NumberANDA214959

Product Classification

Marketing Category

C73584

Generic Name

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 30, 2021

FDA Product Classification

INGREDIENTS (27)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:2)Inactive

Code: XRK36F13ZZ

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQ

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

DEHYDRATED ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 2.5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 2.5 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

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (26)

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (28)

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (26)

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (26)

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (26)

dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (27)

MedPath

Product

Company

Legal