Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 5 mg; 5 mg; 5 mg; 5 mg Tablet, 100-count — NDC 57844-0120-01 package photo

Adderall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 5 mg; 5 mg; 5 mg; 5 mg Tablet, 100-count

by Teva Pharmaceuticals USA, Inc. · 100 TABLET in 1 BOTTLE (57844-120-01)
NDC 57844-0120-01
🏷️ FDA NDC (as labeled) 57844-120-01 billing pads the product segment with a zero
Rx only Generic On market CII ⚠ On shortage
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Active FDA shortage. Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet is currently reported in shortage by the FDA. Available Shortage details →

🆔 Identity & classification

FDA NDC (as labeled) 57844-120-01
Product NDC 57844-120
11-digit billing NDC 57844012001
NCPDP billing unit EA — each (per item)
UNII JJ768O327N, O1ZPV620O4, 6DPV8NK46S, G83415V073
Application # ANDA040422
SPL Set ID f22635fe-821d-4cde-aa12-419f8b53db81
Established class (EPC) Central Nervous System Stimulant; Central Nervo
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-02-11
Route ORAL
Dosage form TABLET
Substance DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
GPI-14 61109902100320
GPI class Adderall
GCN Seq No 005001
GCN 56973
HICL code 013449
Ingredient (HICL) Dextroamphetamine/Amphetamine
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J5
Therapeutic class — intermediate (HIC2) Adrenergics
HIC3 code J5B
Therapeutic class — specific (HIC3) Adrenergics, Aromatic, Non-Catecholamine
AHFS code 28:20.04.00
AHFS class Amphetamines
FDB label name ADDERALL 20 MG TABLET
FDB brand name Adderall
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 57844-120-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 57844-0120-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant
Drug family (ATC) Centrally acting sympathomimetics
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTeva Pharmaceuticals USA, Inc.
Application holderBARR LABORATORIES INC
FDA applicationANDA040422 (ANDA)
Labeler code57844
First marketedFeb 2014
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio504 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ADDERALL 20 MG TABLET Ingredient Dextroamphetamine/Amphetamine
📗 Our plain-language guide HelloPharmacist
  • It helps your brain maintain higher levels of two key signaling chemicals — dopamine and norepinephrine. In people with ADHD, those chemical signals can be inconsistent, making it...
  • What exactly is this medication supposed to do for ADHD?
  • The most common ones, especially at first, are reduced appetite, trouble falling asleep, and sometimes a stomachache or headache. These often improve after your body adjusts to the...
  • What side effects should I actually expect when I first start taking it?
📖 Read our full Amphetamine / Amphetamine Aspartate / Dextroamphetamine / Dextroamphetamine Saccharate guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white / blue / orange
ShapeRound
Imprint3;0;dp
Size1 mm
ScoringScored — splits in 4
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 7CVR7L4A2D
    A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

8 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $12.204 $1,220.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $9.93 $993.35 / 100 tablets
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jan 2024 May 2026 Aug 2026 $12.240 $7.878
▲ Up 55% over the last 8 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 00185-0853-01 Sandoz 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 00406-8893-01 SpecGx 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 00527-0765-37 Lannett 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 00555-0973-02 Teva 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 11534-0195-01 SUNRISE 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 13107-0073-01 Aurolife 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 16714-0953-01 NorthStar 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 31722-0163-01 Camber 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 42806-0344-01 Epic 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 42858-0726-01 Rhodes 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 47781-0179-01 Alvogen 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 64850-0505-01 Elite 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 68462-0652-01 GLENMARK 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 70010-0116-01 Granules 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 72516-0012-01 Oryza 100 tablets $0.295 AB Availability likely save 98%
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 16714-0807-01 Northstar 100 tablets $0.302 AB FDA listed save 98%
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 57664-0646-08 Sun 100 tablets $0.322 AB FDA listed save 97%
Adderall 5 mg/1; 5 mg/1; 5 mg/1; 5 mgthis 57844-0120-01 Teva 100 tablets $12.204 AB Availability likely
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 55466-0132-12 Neolpharma, 100 tablets AB Discontinued
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 72162-2053-01 Bryant 100 tablets AB Discontinued
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate 5 mg/1; 5 mg/1; 5 mg/1; 5 mg 72162-2251-01 Bryant 100 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2014
On the market since
Feb 2014
📍
2026
Currently FDA-listed
12 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 57844-0120-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
14.6K
Units reimbursed last 4 qtrs
827.1K
Gross reimbursed last 4 qtrs
$8.22M
Avg / prescription
$561.04
Avg / unit
$9.9335
Latest quarter Q4 2025
3.5KRx
Medicaid pays / ea
$9.9335
gross reimbursed
vs
NADAC / ea
$12.2040
acquisition cost
=
Spread
−$2.2705
-19% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
58% FFS 42% MCO
Fee-for-service · 8,542 Rx Managed care · 6,103 Rx
State Medicaid map
Alaska: no data reported AK Maine: 3,552 units · 255 per 100k residents ME Washington: 9,389 units · 120 per 100k residents WA Idaho: 4,991 units · 254 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 9,115 units · 159 per 100k residents MN Wisconsin: 226,418 units · 3,831 per 100k residents WI Michigan: 39,943 units · 398 per 100k residents MI New York: 85,431 units · 437 per 100k residents NY Vermont: 3,956 units · 611 per 100k residents VT New Hampshire: 11,738 units · 837 per 100k residents NH Oregon: 1,081 units · 25.5 per 100k residents OR Nevada: 1,875 units · 58.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 3,355 units · 105 per 100k residents IA Illinois: 5,747 units · 45.8 per 100k residents IL Indiana: no data reported IN Ohio: 6,175 units · 52.4 per 100k residents OH Pennsylvania: 43,403 units · 335 per 100k residents PA New Jersey: 12,628 units · 136 per 100k residents NJ Massachusetts: 22,085 units · 315 per 100k residents MA California: 59,263 units · 152 per 100k residents CA Utah: no data reported UT Colorado: 10,599 units · 180 per 100k residents CO Nebraska: 6,716 units · 340 per 100k residents NE Missouri: 5,268 units · 85.0 per 100k residents MO Kentucky: 10,351 units · 229 per 100k residents KY West Virginia: no data reported WV Virginia: 22,001 units · 252 per 100k residents VA Maryland: no data reported MD Connecticut: 43,767 units · 1,210 per 100k residents CT Rhode Island: 7,254 units · 662 per 100k residents RI Arizona: 31,901 units · 429 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 4,628 units · 64.9 per 100k residents TN North Carolina: 50,395 units · 465 per 100k residents NC South Carolina: 3,391 units · 63.1 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 12,266 units · 268 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 65,811 units · 216 per 100k residents TX Florida: 2,645 units · 11.7 per 100k residents FL
Units reimbursed · per 100k residents
11.73,831
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Wisconsin 3,831 /100k
2 Connecticut 1,210 /100k
3 New Hampshire 837 /100k
4 Rhode Island 662 /100k
5 Vermont 611 /100k
6 North Carolina 465 /100k
7 New York 437 /100k
8 Arizona 429 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Adderall — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Adderall. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$2.69M
Claims incl. refills
3.6K
Beneficiaries
1.8K
Spend / beneficiary
$1,517.44
Spend / claim
$754.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Adderall (this brand).

Top reported reactions

Fatigue2,835
Nausea2,627
Headache2,305
Anxiety2,179
Depression1,881
Pain1,645
Feeling Abnormal1,643

Age at onset

Neonate10
Infant7
Child204
Adolescent169
Adult3,676
Elderly355

Reporter sex

35,104 reports
Male · 27%
Female · 72%
Unknown · 1%

Serious outcomes

Disabling865
Death461
Life-threatening458
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 2,528 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
57844-0120-01 You're viewing this 100 TABLET in 1 BOTTLE (57844-120-01) 2014-02-11 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 132 words

WARNING: ABUSE, MISUSE, AND ADDICTION Adderall ® has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Adderall ® , can result in overdose and death [see OVERDOSAGE ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Adderall ® , assess each patient’s risk for abuse, misuse, and addiction.

Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout Adderall ® treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see WARNINGS and DRUG ABUSE AND DEPENDENCE ].

🎯 Indications and Usage 212 words

INDICATIONS AND USAGE Adderall ® (Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product)) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.

The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful.

For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder Not recommended for children under 3 years of age.

In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained. In children 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.

Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Prior to treating patients with Adderall ® , assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS ]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Adderall ® [see WARNINGS ] . Narcolepsy Usual dose 5 mg to 60 mg per day in divided doses, depending on the individual patient response.

Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained.

If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.

Contraindications 74 words

CONTRAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of Adderall ® . Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see ADVERSE REACTIONS ]. 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 DRUG INTERACTIONS ].

⚠️ Warnings ~3 min read

WARNINGS Abuse, Misuse, and Addiction Adderall ® has a high potential for abuse and misuse. The use of Adderall ® exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Adderall ® can be diverted for non-medical use into illicit channels or distribution [see DRUG ABUSE AND DEPENDENCE : Abuse].

Misuse and abuse of CNS stimulants, including Adderall ® , can result in overdose and death [see OVERDOSAGE ], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing Adderall ® assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug.

Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give Adderall ® to anyone else. Throughout Adderall ® treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulant treatment at the recommended ADHD dosages.

Avoid Adderall ® use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Some patients may have larger increases.

Monitor all Adderall ® -treated patients for potential tachycardia and hypertension. Psychiatric Adverse Reactions Exacerbation of Preexisting Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients.

Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients.

If such symptoms occur, consider discontinuing Adderall ® . Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in Adderall ® -treated pediatric patients treated with CNS stimulants.

Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see PRECAUTIONS , PEDIATRIC USE ]. Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud’s Phenomenon Stimulants, including Adderall ® , used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae include digital ulceration and/or soft tissue breakdown. Effects of pe…

🤒 Adverse Reactions 128 words

ADVERSE REACTIONS Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, motor and verbal tics, aggression, anger, logorrhea, dermatillomania.

Eye Disorders Vision blurred, mydriasis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia, and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.

Allergic Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido, frequent or prolonged erections.

Skin Alopecia. Musculoskeletal Rhabdomyolysis. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy ~1 min read

Pregnancy Teratogenic Effects Amphetamine, in the enantiomer ratio present in Adderall ® (d- to l- ratio of 3:1), had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m 2 body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m 2 basis) or greater to pregnant animals.

Administration of these doses was also associated with severe maternal toxicity. A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,l-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. Amphetamines should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

🧒 Pediatric Use 37 words

Pediatric Use Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under INDICATIONS AND USAGE .

🧓 Geriatric Use 12 words

Geriatric Use Adderall ® has not been studied in the geriatric population.

🆘 Overdosage 96 words

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. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Pharmacodynamics Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Pharmacokinetics Adderall ® tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of Adderall ® to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l-amphetamine. The mean elimination half-life (t 1/2 ) for d-amphetamine was shorter than the t 1/2 of the l-isomer (9.77 to 11 hours vs.

11.5to 13.8 hours). The PK parameters (C max , AUC 0-inf ) of d-and l-amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics. The effect of food on the bioavailability of Adderall ® has not been studied.

Metabolism and Excretion Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4-hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenylacetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid.

Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility. Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated.

In vitro experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to in vivo concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes in vivo can be made. With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose is recoverable in urine as amphetamine itself.

Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized.

Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that affect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine’s metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased [see PRECAUTIONS ].

📦 How Supplied / Storage and Handling ~2 min read

HOW SUPPLIED Adderall ® (Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product)) is supplied as follows: 5 mg: White to off-white, round, flat-faced beveled edge tablet with four partial bisects debossed with 5 on one side and debossed with dp on the other side. They are available in bottles of 100 tablets (NDC 57844-105-01). 7.5 mg: Blue, oval, biconvex tablet with two partial bisects debossed with 7.5 on one side and one full bisect and two partial bisects debossed with d | p on the other side.

They are available in bottles of 100 tablets (NDC 57844-117-01). 10 mg: Blue, round, biconvex tablet with one full bisect and two partial bisects debossed with 1 | 0 on one side and debossed with dp on the other side. They are available in bottles of 100 tablets (NDC 57844-110-01).

12.5mg: Peach, round, flat-faced beveled edge tablet debossed with 12.5 on one side and one full bisect and two partial bisects debossed with d | p on the other side. They are available in bottles of 100 tablets (NDC 57844-112-01). 15 mg: Peach, oval, biconvex tablet with two partial bisects debossed with 15 on one side and one full bisect and two partial bisects debossed with d | p on the other side.

They are available in bottles of 100 tablets (NDC 57844-115-01). 20 mg: Peach, round, biconvex tablet with one full bisect and two partial bisects debossed with 2 | 0 on one side and debossed with dp on the other side. They are available in bottles of 100 tablets (NDC 57844-120-01).

30 mg: Peach, round, flat-faced beveled edge tablet with one full bisect and 2 partial bisects debossed with 3 | 0 on one side and dp on the other side. They are available in bottles of 100 tablets (NDC 57844-130-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Brands listed are trademarks of their respective owners.

Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. O 5/2024

📋 Description ~1 min read

DESCRIPTION A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. EACH TABLET CONTAINS 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate Equivalent 1.25 mg 1 1.875 mg 2 2.5 mg 3 3.125 mg 4 3.75 mg 5 5 mg 6 7.5 mg 7 Dextroamphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg 1 1.25 mg of Amphetamine Aspartate Monohydrate equivalent to 1.17 mg Amphetamine Aspartate (Anhydrous) as supplied 2 1.875 mg of Amphetamine Aspartate Monohydrate equivalent to 1.755 mg Amphetamine Aspartate (Anhydrous) as supplied 3 2.5 mg of Amphetamine Aspartate Monohydrate equivalent to 2.34 mg Amphetamine Aspartate (Anhydrous) as supplied 4 3.125 mg of Amphetamine Aspartate Monohydrate equivalent to 2.925 mg Amphetamine Aspartate (Anhydrous) as supplied 5 3.75 mg of Amphetamine Aspartate Monohydrate equivalent to 3.51 mg Amphetamine Aspartate (Anhydrous) as supplied 6 5 mg of Amphetamine Aspartate Monohydrate equivalent to 4.6 mg Amphetamine Aspartate (Anhydrous) as supplied 7 7.5 mg of Amphetamine Aspartate Monohydrate equivalent to 7.03 mg Amphetamine Aspartate (Anhydrous) as supplied Inactive Ingredients: colloidal silicon dioxide, compressible sugar (sucrose and maltodextrin), corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium.

Colors: Adderall ® 5 mg is a white to off-white tablet, which contains no color additives. Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Adderall ® 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.

💬 Medication Guide ~3 min read

MEDICATION GUIDE MEDICATION GUIDE Adderall ® ( ADD-ur-all ) CII (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product)) What is the most important information I should know about Adderall ® ? Adderall ® may cause serious side effects, including: Abuse, misuse, and addiction. Adderall ® has a high chance for abuse and misuse and may lead to substance use problems, including addiction.

Misuse and abuse of Adderall ® , other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Adderall ® or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Adderall ® and will monitor you or your child during treatment.

Adderall ® may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Adderall ® to anyone else. See “ What is Adderall ® ?” for more information.

Keep Adderall ® in a safe place and properly dispose of any unused medicine. See “ How should I store Adderall ® ?” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Adderall ® . Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Adderall ® . Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Adderall ® .

Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Adderall ® , especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

What is Adderall ® ? Adderall ® is a central nervous system (CNS) stimulant prescription medicine used for the treatment of: Attention-Deficit Hyperactivity Disorder (ADHD) in children 3 to 17 years of age. Adderall ® may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. a sleep disorder called narcolepsy in people 6 years and older.

It is not known if Adderall ® is safe and effective in children with ADHD under 3 years of age. It is not known if Adderall ® is safe and effective in children with Narcolepsy under 6 years of age. Adderall ® is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs.

Keep Adderall ® in a safe place to protect it from theft. Never give your Adderall ® to anyone else because it may cause death or harm them. Selling or giving away Adderall ® may harm others and is against the law.

Do not take Adderall ® if you or your child: are allergic to amphetamine products or any of the ingredients in Adderall ® . See the end of this Medicat…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.