Adderall XR

Basic Information

Product Name

Adderall XR

FDA Product Code

54868-5142

Regulatory Information

NDC Product Code

54868-5142

Application Number

NDA021303

Marketing Category

C73594

Effective Date

November 16, 2010

Territorial Authority

USA

FDA Title

These highlights do not include all the information needed to use ADDERALL XR safely and effectively. See full prescribing information for ADDERALL XR. ADDERALL XR (mixed salts of a single-entity amphetamine product) dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulfate capsules, CII Initial U.S. Approval: 2001

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

DEXTROAMPHETAMINE SULFATE

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Class Code: ACTIB

AMPHETAMINE SULFATE

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TRIETHYL CITRATE

Code: 8Z96QXD6UM

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

DEXTROAMPHETAMINE SACCHARATE

Quantity: 7.5 mg in 1 1

Code: G83415V073

Class Code: ACTIB

AMPHETAMINE ASPARTATE

Quantity: 7.5 mg in 1 1

Code: H527KAP6L5

Class Code: ACTIB

Active Moieties

DEXTROAMPHETAMINE

Code: TZ47U051FI

AMPHETAMINE

Code: CK833KGX7E

Basic Information

Regulatory Information

Company Information

Active Ingredients

GELATIN

HYPROMELLOSES

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

SUCROSE

TALC

TRIETHYL CITRATE

FERRIC OXIDE RED

FERRIC OXIDE YELLOW

Active Moieties

DEXTROAMPHETAMINE

AMPHETAMINE