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FDA Approval

Dexmethylphenidate hydrochloride

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

FDA Approval Summary

Company

Sun Pharmaceutical Industries, Inc.

DUNS: 146974886

Effective Date

January 16, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Dexmethylphenidate(40 mg in 1 1)

Manufacturing Establishments1

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

Ohm Laboratories Inc.

Labeler

Sun Pharmaceutical Industries, Inc.

DUNS Number

184769029

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

57664-626

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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

Code: 74G4R6TH13Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

DexmethylphenidateActive

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

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-621

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

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

Code: 74G4R6TH13Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

DexmethylphenidateActive

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

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-623

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NHClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

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

Code: 74G4R6TH13Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

DexmethylphenidateActive

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

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-625

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

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

Code: 74G4R6TH13Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

DexmethylphenidateActive

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

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-629

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

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

Code: 74G4R6TH13Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

DexmethylphenidateActive

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

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-628

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

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

Code: 74G4R6TH13Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

DexmethylphenidateActive

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

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-624

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

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

Code: 74G4R6TH13Class: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

DexmethylphenidateActive

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

Dexmethylphenidate hydrochloride

Product Details

NDC Product Code

57664-622

Application Number

ANDA206734

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 16, 2024

Ingredients

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2Class: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

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

Code: 74G4R6TH13Class: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)Inactive

Code: 5KY68S2577Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRTClass: IACT

DexmethylphenidateActive

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

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