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FDA Approval

Methylphenidate Hydrochloride

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

FDA Approval Summary

Company

Granules Pharmaceuticals Inc.

DUNS: 079825711

Effective Date

November 1, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Methylphenidate(10 mg in 1 1)

Manufacturing Establishments1

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

Granules Pharmaceuticals Inc.

Labeler

Granules Pharmaceuticals Inc.

DUNS Number

079825711

Products5

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

Methylphenidate Hydrochloride

Product Details

NDC Product Code

70010-012

Application Number

ANDA211796

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 1, 2023

Ingredients

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive

Code: 6N003M473WClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SHELLACInactive

Code: MB5IUD6JUAClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)Inactive

Code: BEI30UXK2NClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MethylphenidateActive

Code: 4B3SC438HIClass: ACTIBQuantity: 10 mg in 1 1

Methylphenidate Hydrochloride

Product Details

NDC Product Code

70010-014

Application Number

ANDA211796

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 1, 2023

Ingredients

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)Inactive

Code: BEI30UXK2NClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive

Code: 6N003M473WClass: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

MethylphenidateActive

Code: 4B3SC438HIClass: ACTIBQuantity: 30 mg in 1 1

Methylphenidate Hydrochloride

Product Details

NDC Product Code

70010-015

Application Number

ANDA211796

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 1, 2023

Ingredients

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZClass: IACT

CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)Inactive

Code: BEI30UXK2NClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive

Code: 6N003M473WClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

MethylphenidateActive

Code: 4B3SC438HIClass: ACTIBQuantity: 40 mg in 1 1

Methylphenidate Hydrochloride

Product Details

NDC Product Code

70010-016

Application Number

ANDA211796

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 1, 2023

Ingredients

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZClass: IACT

CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)Inactive

Code: BEI30UXK2NClass: IACT

HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive

Code: 6N003M473WClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

FD&C YELLOW NO. 5Inactive

Code: I753WB2F1MClass: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

MethylphenidateActive

Code: 4B3SC438HIClass: ACTIBQuantity: 60 mg in 1 1

Methylphenidate Hydrochloride

Product Details

NDC Product Code

70010-013

Application Number

ANDA211796

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

November 1, 2023

Ingredients

CELLABURATE (MW 65000, 17% BUTYRYL, 30% ACETYL)Inactive

Code: BEI30UXK2NClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

POLYETHYLENE GLYCOLInactive

Code: 3WJQ0SDW1AClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

ACETYLTRIBUTYL CITRATEInactive

Code: 0ZBX0N59RZClass: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive

Code: 6N003M473WClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MethylphenidateActive

Code: 4B3SC438HIClass: ACTIBQuantity: 20 mg in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

TALCInactive

Code: 7SEV7J4R1UClass: IACT

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