DEXMETHYLPHENIDATE HYDROCHLORIDE

Manufacturing Establishments1

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

Ascent Pharmaceuticals, Inc.

Labeler

Camber 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.

Product Details

NDC Product Code

31722-233

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

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

Code: 74G4R6TH13Class: IACT

DexmethylphenidateActive

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

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: 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

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-232

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

ACETONEInactive

Code: 1364PS73AFClass: 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

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

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

SUCROSEInactive

Code: C151H8M554Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-229

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQYClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

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

ACETONEInactive

Code: 1364PS73AFClass: 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

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-231

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

DexmethylphenidateActive

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

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE AInactive

Code: 8GQS4E66YYClass: 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

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-230

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DexmethylphenidateActive

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

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: 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

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-235

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 35 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

ACETONEInactive

Code: 1364PS73AFClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-236

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

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

Code: 74G4R6TH13Class: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DexmethylphenidateActive

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

POLYETHYLENE GLYCOL 6000Inactive

Code: 30IQX730WEClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

ACETONEInactive

Code: 1364PS73AFClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

NDC Product Code

31722-234

Application Number

ANDA215523

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 17, 2021

Ingredients

DexmethylphenidateActive

Code: 1678OK0E08Class: ACTIBQuantity: 30 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

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

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DEXMETHYLPHENIDATE HYDROCHLORIDE

FDA Approval Summary

Manufacturing Establishments1

Products8

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Details