Clinical Trials

Find trials by condition, location & phase

Drug Monographs

Browse drug monographs and information

Explore organizations and their profiles

Latest updates on trials and healthcare

Approved products by global authorities

AI-Powered Research

Discover powerful insights with advanced AI analysis tools for clinical trials.

Premium Access

Get unlimited access to our comprehensive pharmaceutical database and analytics.

FDA Approval

DEXMETHYLPHENIDATE HYDROCHLORIDE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Ascent Pharmaceuticals, Inc.

DUNS: 080938961

Effective Date

December 10, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dexmethylphenidate(5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Ascent Pharmaceuticals, Inc.

Labeler

Ascent Pharmaceuticals, Inc.

DUNS Number

080938961

Products8

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

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-327

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 5 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-330

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 20 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-329

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 15 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YYClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-328

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 10 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-334

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 40 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-333

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 35 mg in 1 1

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-332

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 30 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

43602-331

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 10, 2021

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 25 mg in 1 1

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy