APTENSIO XR

These highlights do not include all the information needed to use APTENSIO XR safely and effectively. See full prescribing information for APTENSIO XR. APTENSIO XR (methylphenidate hydrochloride extended-release) capsules, for oral use, CII Initial U.S. Approval: 1955

Approved

Approval ID

5adedc01-ebf0-11e3-ac10-0800200c9a66

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 23, 2023

Manufacturers

FDA

Rhodes Pharmaceuticals L.P.

DUNS: 831928986

Products 7

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

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-406

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (15)

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1S

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-405

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (16)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 40 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-407

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (14)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 60 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-402

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (16)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 15 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

D&C RED NO. 28Inactive

Code: 767IP0Y5NH

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-401

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (14)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-404

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (15)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 30 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FD&C RED NO. 3Inactive

Code: PN2ZH5LOQY

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

(methylphenidate hydrochloride)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code42858-403

Application NumberNDA205831

Product Classification

Marketing Category

C73594

Generic Name

(methylphenidate hydrochloride)

Product Specifications

Route of AdministrationORAL

Effective DateOctober 23, 2023

FDA Product Classification

INGREDIENTS (15)

METHYLPHENIDATE HYDROCHLORIDEActive

Quantity: 20 mg in 1 1

Code: 4B3SC438HI

Classification: ACTIB

SUCROSEInactive

Code: C151H8M554

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

AMMONIO METHACRYLATE COPOLYMER TYPE BInactive

Code: 161H3B14U2

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

D&C RED NO. 33Inactive

Code: 9DBA0SBB0L

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

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APTENSIO XR

Products 7

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

(methylphenidate hydrochloride)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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