NDC 54092-391 Adderall XR
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate Capsule, Extended Release Oral

Product Information

Adderall XR is a human prescription drug product labeled by Takeda Pharmaceuticals America, Inc.. The generic name of Adderall XR is dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine sulfate and amphetamine aspartate. The product's dosage form is capsule, extended release and is administered via oral form.

Product Code54092-391
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Adderall XR
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Prescription Drug
Dosage FormCapsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Takeda Pharmaceuticals America, Inc.
Labeler Code54092
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
NDA021303
DEA Schedule What is the Drug Enforcement Administration (DEA) CII Schedule?
The controlled substances in the CII schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the United States. Schedule CII controlled substances include certain narcotic, stimulant, and depressant drugs.
Schedule II (CII) Substances
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
10-11-2001
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Adderall XR?


Product Characteristics

Color(s)BLUE (C48333 - BLUE)
WHITE (C48325 - WHITE)
ORANGE (C48331 - ORANGE)
BROWN (C48332 - BROWN)
ShapeCAPSULE (C48336)
Size(s)16 MM
18 MM
21 MM
Imprint(s)ADDERALL;XR;5;MG
ADDERALL;XR;10;MG
ADDERALL;XR;15;MG
ADDERALL;XR;20;MG
ADDERALL;XR;25;MG
ADDERALL;XR;30;MG
Score1

Product Packages

NDC 54092-391-01

Package Description: 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $6.84347 per EA

Product Details

What are Adderall XR Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg/1
  • AMPHETAMINE SULFATE 7.5 mg/1 - A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.
  • DEXTROAMPHETAMINE SACCHARATE 7.5 mg/1
  • DEXTROAMPHETAMINE SULFATE 7.5 mg/1 - The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 861221 - dextroamphetamine saccharate 2.5 MG / amphetamine aspartate 2.5 MG / dextroamphetamine sulfate 2.5 MG / amphetamine sulfate 2.5 MG 24HR Extended Release Oral Capsule
  • RxCUI: 861221 - 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule
  • RxCUI: 861221 - amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 861222 - ADDERALL XR 10 MG 24HR Extended Release Oral Capsule
  • RxCUI: 861222 - 24 HR amphetamine aspartate 2.5 MG / amphetamine sulfate 2.5 MG / dextroamphetamine saccharate 2.5 MG / dextroamphetamine sulfate 2.5 MG Extended Release Oral Capsule [Adderall]

Inactive Ingredient(s)

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
  • SUCROSE (UNII: C151H8M554)
  • TALC (UNII: 7SEV7J4R1U)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Dextroamphetamine and Amphetamine

Dextroamphetamine and Amphetamine is pronounced as (dex troe am fet' a meen) (am fet' a meen)

Why is dextroamphetamine and amphetamine medication prescribed?
The combination of dextroamphetamine and amphetamine is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more di...
[Read More]

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Adderall XR Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



5.6 Serotonin Syndrome



Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as MAOIs, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see DRUG INTERACTIONS (7.1)]. Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism [see CLINICAL PHARMACOLOGY (12.3)]. The potential for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to ADDERALL XR. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see DRUG INTERACTIONS (7.1)]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of ADDERALL XR with MAOI drugs is contraindicated [see CONTRAINDICATIONS (4)].

Discontinue treatment with ADDERALL XR and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment. Concomitant use of ADDERALL XR with other serotonergic drugs or CYP2D6 inhibitors should be used only if the potential benefit justifies the potential risk. If clinically warranted, consider initiating ADDERALL XR with lower doses, monitoring patients for the emergence of serotonin syndrome during drug initiation or titration, and informing patients of the increased risk for serotonin syndrome.


17.6 Serotonin Syndrome



Caution patients about the risk of serotonin syndrome with concomitant use of ADDERALL XR and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see CONTRAINDICATIONS (4), WARNINGS AND PRECAUTIONS (5.6) and DRUG INTERACTIONS (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.


17.7 Concomitant Medications



Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see DRUG INTERACTIONS (7.1)].


Principal Display Panel - 5 Mg Capsule Bottle Label



NDC 54092-381-01

ADDERALL XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

5 mg

CII
100 Capsules

Rx only

Shire


Principal Display Panel - 10 Mg Capsule Bottle Label



NDC 54092-383-01

ADDERALL XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

10 mg

CII
100 Capsules

Rx only

Shire


Principal Display Panel - 15 Mg Capsule Bottle Label



NDC 54092-385-01

ADDERALL XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

15 mg

CII
100 Capsules

Rx only

Shire


Principal Display Panel - 20 Mg Capsule Bottle Label



NDC 54092-387-01

ADDERALL XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

20 mg

CII
100 Capsules

Rx only

Shire


Principal Display Panel - 25 Mg Capsule Bottle Label



NDC 54092-389-01

ADDERALL XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

25 mg

CII
100 Capsules

Rx only

Shire


Principal Display Panel - 30 Mg Capsule Bottle Label



NDC 54092-391-01

ADDERALL XR®

(Mixed Salts of A Single-Entity
Amphetamine Product)

Extended-Release Capsules

30 mg

CII
100 Capsules

Rx only

Shire


* Please review the disclaimer below.