LISDEXAMFETAMINE DIMESYLATE

Boxed Warning 10/2023 Dosage and Administration ( 2.1 ) 10/2023 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.8 ) 10/2023

1 INDICATIONS AND USAGE Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies ( 14.1 )] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies ( 14.2 )] . Limitations of Use: The use of lisdexamfetamine dimesylate is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5), Use in Specific Populations (8.4)]. Lisdexamfetamine dimesylate is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate for the treatment of obesity have not been established [see Warnings and Precautions ( 5.2 )] . Lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets are a central nervous system (CNS) stimulant indicated for the treatment of ( 1 ): Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older Moderate to severe binge eating disorder (BED) in adults Limitations of Use: The use of lisdexamfetamine dimesylate is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage (5.5, 8.4) Lisdexamfetamine dimesylate is not indicated for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of lisdexamfetamine dimesylate for the treatment of obesity have not been established ( 5.2 )

2 DOSAGE AND ADMINISTRATION Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) ( 2.2 ) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) ( 2.3 ) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day Prior to treatment, assess for presence of cardiac disease ( 2.4 ) Severe renal impairment: Maximum dose is 50 mg/day ( 2.5 ) End stage renal disease (ESRD): Maximum dose is 30 mg/day ( 2.5 ) 2.1 Pre-treatment Screening Prior to treating patients with CNS stimulants, including lisdexamfetamine dimesylate capsules, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . To reduce the abuse of CNS stimulants including lisdexamfetamine dimesylate capsules, assess the risk of abuse, prior to prescribing. After prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and re-evaluate the need for lisdexamfetamine dimesylate capsules use [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9 )] . 2.2 General Instructions for Use Take lisdexamfetamine dimesylate capsule by mouth in the morning with or without food; avoid afternoon doses because of the potential for insomnia. Lisdexamfetamine dimesylate capsules may be administered in one of the following ways: Information for lisdexamfetamine dimesylate capsules: Swallow lisdexamfetamine dimesylate capsules whole, or Open capsules, empty and mix the entire contents with yogurt, water, or orange juice. If the contents of the capsule include any compacted powder, a spoon may be used to break apart the powder. The contents should be mixed until completely dispersed. Consume the entire mixture immediately. It should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed. Lisdexamfetamine dimesylate capsules can be substituted with lisdexamfetamine dimesylate chewable tablets on a unit per unit/mg per mg basis (for example, 30 mg capsules for 30 mg chewable tablet) [see Clinical Pharmacology ( 12.3 )] . Do not take anything less than one capsule per day. A single dose should not be divided. 2.3 Dosage for Treatment of ADHD The recommended starting dosage in adults and pediatric patients 6 years and older is 30 mg once daily in the morning. Dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals up to maximum recommended dosage of 70 mg once daily [see Clinical Studies ( 14.1 )] . 2.4 Dosage for Treatment of Moderate to Severe BED in Adults The recommended starting dosage in adults is 30 mg once daily to be titrated in increments of 20 mg at approximately weekly intervals to achieve the recommended target dose of 50 mg to 70 mg once daily. The maximum recommended dosage is 70 mg once daily [see Clinical Studies ( 14.2 )] . Discontinue lisdexamfetamine dimesylate capsules if binge eating does not improve. 2.5 Dosage in Patients with Renal Impairment In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m 2 ), the maximum dosage should not exceed 50 mg once daily. In patients with end stage renal disease (ESRD, GFR < 15 mL/min/1.73 m 2 ), the maximum recommended dosage is 30 mg once daily [see Use in Specific Populations ( 8.6 )] . 2.6 Dosage Modifications due to Drug Interactions Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust lisdexamfetamine dimesylate capsules dosage accordingly [see Drug Interactions ( 7.1 )] .

3 DOSAGE FORMS AND STRENGTHS Lisdexamfetamine Dimesylate Capsules are available containing 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg or 70 mg of lisdexamfetamine dimesylate. • The 10 mg capsules are hard-shell gelatin capsules with a purple opaque cap and purple opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 10 in black ink on cap and body. • The 20 mg capsules are hard-shell gelatin capsules with an ivory opaque cap and ivory opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 20 in black ink on cap and body. • The 30 mg capsules are hard-shell gelatin capsules with an orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 30 in black ink on cap and body. • The 40 mg capsules are hard-shell gelatin capsules with a green opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 40 in black ink on cap and body. • The 50 mg capsules are hard-shell gelatin capsules with a blue opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 50 in black ink on cap and body. • The 60 mg capsules are hard-shell gelatin capsules with a blue opaque cap and blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 60 in black ink on cap and body. • The 70 mg capsules are hard-shell gelatin capsules with an orange opaque cap and blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 70 in black ink on cap and body. Capsules: 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg ( 3 )

4 CONTRAINDICATIONS Lisdexamfetamine dimesylate is contraindicated in patients with: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports [see Adverse Reactions ( 6.2 )] . Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see Warnings and Precautions ( 5.7 ) and Drug Interactions ( 7.1 )]. Known hypersensitivity to amphetamine products or other ingredients in lisdexamfetamine dimesylate capsules and lisdexamfetamine dimesylate chewable tablets ( 4 ) Use with monoamine oxidase (MAO) inhibitor, or within 14 days of the last MAO inhibitor dose ( 4 , 7.1 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules [see Contraindications (4) ] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1) ] Abuse, Misuse, and Addiction [see Boxed Warning , Warnings and Precautions (5.1) , and Drug Abuse and Dependence (9.2 , 9.3) ] Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions (5.2) ] Increased Blood Pressure and Heart Rate [see Warnings and Precautions (5.3) ] Psychiatric Adverse Reactions [see Warnings and Precautions (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see Warnings and Precautions (5.6) ] Serotonin Syndrome [see Warnings and Precautions (5.7) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in pediatric patients ages 6 to 17 years, and/or adults with ADHD were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. ( 6.1 ) Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in adults with BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rhodes Pharmaceuticals LLC at 1-888-873-5329 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Attention Deficit Hyperactivity Disorder The safety data in this section is based on data from the 4-week controlled parallel-group clinical studies of lisdexamfetamine dimesylate capsules in pediatric and adult patients with ADHD [see Clinical Studies (14.1) ] . Adverse Reactions Associated with Discontinuation of Treatment in ADHD Clinical Trials In the controlled trial in pediatric patients ages 6 to 12 years (Study 1), 8% (18/218) of lisdexamfetamine dimesylate capsules-treated patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)]. Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger, and hypertension. In the controlled trial in pediatric patients ages 13 to 17 years (Study 4), 3% (7/233) of lisdexamfetamine dimesylate capsules-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea. In the controlled adult trial (Study 7), 6% (21/358) of lisdexamfetamine dimesylate capsules-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/ …

7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter urinary pH can alter blood levels of amphetamine. Acidifying agents decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels. Adjust lisdexamfetamine dimesylate capsules dosage accordingly. ( 2.6 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Amphetamines Table 5 Drugs having clinically important interactions with amphetamines. MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Intervention Do not administer lisdexamfetamine dimesylate capsules during or within 14 days following the administration of MAOI [see Contraindications (4) ] . Serotonergic Drugs Clinical Impact The concomitant use of lisdexamfetamine dimesylate capsules and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during lisdexamfetamine dimesylate capsules initiation or dosage increase. If serotonin syndrome occurs, discontinue lisdexamfetamine dimesylate capsules and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.7) ] . CYP2D6 Inhibitors Clinical Impact The concomitant use of lisdexamfetamine dimesylate capsules and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of lisdexamfetamine dimesylate capsules, compared to the use of the drug alone and increase the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during lisdexamfetamine dimesylate capsules initiation and after a dosage increase. If serotonin syndrome occurs, discontinue lisdexamfetamine dimesylate capsules and the CYP2D6 inhibitor [see Warnings and Precautions (5.7) and Overdosage (10) ] . Alkalinizing Agents Clinical Impact Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine. Intervention Co-administration of lisdexamfetamine dimesylate capsules and urinary alkalinizing agents should be avoided. Acidifying Agents Clinical Impact Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Intervention Increase dose based on clinical response. Tricyclic Antidepressants Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response. 7.2 Drugs Having No Clinically Important Interactions with Lisdexamfetamine Dimesylate Capsules From a pharmacokinetic perspective, no dose adjustment of lisdexamfetamine dimesylate capsules is necessary when lisdexamfetamine dimesylate capsules are co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when lisdexamfetamine dimesylate capsules are co-administered [see Clinical Pharmacology (12.3) ] . From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g., theophylline, duloxetine, melatonin), CYP2D6 (e.g., atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g., omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g., midazolam, pimozide, simvastatin) is necessary when lisdexamfetamine dimesylate capsules are co-administered [see Clinical Pharmacology (12.3) ] .

8 USE IN SPECIFIC POPULATIONS Pregnancy : May cause fetal harm ( 8.1 ) Lactation: Breastfeeding not recommended ( 8.2 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and researchprograms/pregnancyregistry/adhdmedications/. Risk Summary The limited available data from published literature and postmarketing reports on use of lisdexamfetamine dimesylate in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines [see Clinical Considerations] . In animal reproduction studies, lisdexamfetamine dimesylate (a prodrug of d-amphetamine) had no effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis. Pre- and postnatal studies were not conducted with lisdexamfetamine dimesylate. However, amphetamine (d- to l- ratio of 3:1) administration to pregnant rats during gestation and lactation caused a decrease in pup survival and a decrease in pup body weight that correlated with a delay in developmental landmarks at clinically relevant doses of amphetamine. In addition, adverse effects on reproductive performance were observed in pups whose mothers were treated with amphetamine. Long-term neurochemical and behavioral effects have also been reported in animal developmental studies using clinically relevant doses of amphetamine [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Amphetamines, such as lisdexamfetamine dimesylate, cause vasoconstriction and thereby may decrease placental perfusion. In addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. Infants born to amphetamine-dependent mothers have an increased risk of premature delivery and low birth weight. Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness. Data Animal Data Lisdexamfetamine dimesylate had no apparent effects on embryo-fetal morphological development or survival when administered orally to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 40 mg/kg/day and 120 mg/kg/day, respectively. These doses are approximately 5.5 and 33 times, respectively, the maximum recommended human dose (MRHD) of 70 mg/day given to adults, on a mg/m 2 body surface area basis. A study was conducted with amphetamine (d- to l- enantiomer ratio of 3:1) in which pregnant rats received daily oral doses of 2 mg/kg, 6 mg/kg, and 10 mg/kg from gestation day 6 to lactation day 20. All doses caused hyperactivity and decreased weight gain in the dams. A decrease in pup survival was seen at all doses. A decrease in pup body weight was seen at 6 mg/kg and 10 mg/kg which correlated with delays in developmental landmarks, such as preputial separation and vaginal opening. Increased pup locomotor activity was seen at 10 mg/kg on day 22 postpartum but not at 5 weeks postweaning. When pups were tested for reproductive performance at maturation, gestational weight gain, number of implantations, and number of delivered pups were decrease …

12.1 Mechanism of Action Lisdexamfetamine is a prodrug of dextroamphetamine. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD and BED is not known.

11 DESCRIPTION Lisdexamfetamine dimesylate, a CNS stimulant, is a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S )-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate. The molecular formula is C 15 H 25 N 3 O•(CH 4 O 3 S) 2 , which corresponds to a molecular weight of 455.60. The chemical structure is: Lisdexamfetamine dimesylate is a white to off-white powder that is soluble in water (792 mg/mL). Lisdexamfetamine dimesylate capsules contain 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg of lisdexamfetamine dimesylate (equivalent to 5.8 mg, 11.6 mg, 17.3 mg, 23.1 mg, 28.9 mg, 34.7 mg, and 40.5 mg of lisdexamfetamine) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose (Avicel PH 102), povidone K29/32. In addition the 10 mg hard gelatin capsules contain: Iron red oxide, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 20 mg hard gelatin capsules contain: FD&C yellow No. 5, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 30 mg hard gelatin capsules contain: FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 40 mg hard gelatin capsules contain: FD&C blue No. 1, FD & C yellow No. 5, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 50 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 60 mg hard gelatin capsules contain: FD&C blue No. 1, FD&C red No. 3, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. 70 mg hard gelatin capsules contain: FD&C red No. 40, FD&C yellow No. 6, gelatin, opacode black S-1-8114/S-1-8115, titanium dioxide. Opacode black S-1-8114 consists of: shellac glaze, iron oxide black, N-Butyl alcohol, propylene glycol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. Opacode black S-1-8115 consists of: shellac glaze, iron oxide black, SDA 3A alcohol, FD&C blue No. 2/Indigo carmine aluminum lake, FD&C red No. 40/Allura red AC aluminum lake, FD&C blue No. 1/Brilliant blue FCF aluminum lake, and D&C yellow No. 10 aluminum lake. chemicalstructure

10 OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of lisdexamfetamine dimesylate capsules should be considered when treating patients with overdose. Lisdexamfetamine and d-amphetamine are not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Lisdexamfetamine Dimesylate Capsules: Lisdexamfetamine dimesylate capsules 10 mg: White to off-white powder filled in pink opaque cap and pink opaque body imprinted with 'RM46' on cap and '10 mg' on body in black ink, bottles of 100 CRC, NDC 57664-046-88 Lisdexamfetamine dimesylate capsules 20 mg: White to off-white powder filled in off white opaque cap and off white opaque imprinted with 'RM47' on cap and '20 mg' on body in black ink, bottles of 100 CRC, NDC 57664-047-88 Lisdexamfetamine dimesylate capsules 30 mg: White to off-white powder filled in orange opaque cap and white opaque body imprinted with 'RM48' on cap and '30 mg' on body in black ink, bottles of 100 CRC, NDC 57664-048-88 Lisdexamfetamine dimesylate capsules 40 mg: White to off-white powder filled dark green opaque cap and white opaque body imprinted with 'RM49' on cap and '40 mg' on body in black ink, bottles of 100 CRC, NDC 57664-049-88 Lisdexamfetamine dimesylate capsules 50 mg: White to off-white powder filled in blue opaque cap and white opaque body imprinted with 'RM50' on cap and '50 mg' on body in black ink, bottles of 100 CRC, NDC 57664-050-88 Lisdexamfetamine dimesylate capsules 60 mg: White to off-white powder filled in aqua blue opaque cap and aqua blue opaque body imprinted with 'RM51' on cap and '60 mg' on body in black ink, bottles of 100 CRC, NDC 57664-051-88 Lisdexamfetamine dimesylate capsules 70 mg: White to off-white powder filled in blue opaque cap and orange opaque body imprinted with 'RM52' on cap and '70 mg' on body in black ink, bottles of 100 CRC, NDC 57664-052-88 Lisdexamfetamine Dimesylate Chewable Tablets: Lisdexamfetamine dimesylate chewable tablets 10 mg: White to off-white round shaped tablet debossed with ‘10’ on one side and ‘S83’ on the other side, bottles of 100 CRC, NDC 57664-083-88 Lisdexamfetamine dimesylate chewable tablets 20 mg: White to off-white hexagonal shaped tablet debossed with ‘20’ on one side and ‘S84’ on the other side, bottles of 100 CRC, NDC 57664-084-88 Lisdexamfetamine dimesylate chewable tablets 30 mg: White to off-white arc triangular shaped tablet debossed with ‘30’ on one side and ‘S85’ on the other side, bottles of 100 CRC, NDC 57664-085-88 Lisdexamfetamine dimesylate chewable tablets 40 mg: White to off-white capsule shaped tablet debossed with ‘40’ on one side and ‘S86’ on the other side, bottles of 100 CRC, NDC 57664-086-88 Lisdexamfetamine dimesylate chewable tablets 50 mg: White to off-white arc square shaped tablet debossed with ‘50’ on one side and ‘S87’ on the other side, bottles of 100 CRC, NDC 57664-087-88 Lisdexamfetamine dimesylate chewable tablets 60 mg: White to off-white arc diamond shaped tablet debossed with ‘60’ on one side and ‘S88’ on the other side, bottles of 100 CRC, NDC 57664-088-88 16.2 Storage and Handling Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature 20oC to 25oC (68oF to 77oF); excursions permitted between 15oC to 30oC (59oF to 86oF) [see USP Controlled Room Temperature] .