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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg Tablet, 100-count — NDC 68462-0647-01 package photo

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg Tablet, 100-count

by GLENMARK PHARMACEUTICALS INC., USA · 100 TABLET in 1 BOTTLE (68462-647-01)
NDC 68462-0647-01
🏷️ FDA NDC (as labeled) 68462-647-01 billing pads the product segment with a zero
Rx only Generic On market CII
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 68462-647-01
Product NDC 68462-647
11-digit billing NDC 68462064701
NCPDP billing unit EA — each (per item)
RxCUI 541363, 541878, 541892, 577957, 577961
UNII 6DPV8NK46S, G83415V073, H527KAP6L5, JJ768O327N
UPC 0368462651018, 0368462649015, 0368462652015, 0368462647011 +1 more
Application # ANDA210754
SPL Set ID 4564e404-8d71-4585-ab78-55857f477143
Established class (EPC) Central Nervous System Stimulant
Physiologic effect Central Nervous System Stimulation
DEA schedule CII
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-12
Route ORAL
Dosage form TABLET
Substance DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE; AMPHETAMINE DL-ASPARTATE; DEXTROAMPHETAMINE SACCHARATE
GPI-14 61109902100305
GCN Seq No 004999
GCN 56970
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 DEXTROAMP-AMPHETAMINE 5 MG TAB
FDB brand name Dextroamphetamine-Amphetamine
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 68462-647-01 — 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 → 68462-0647-01. 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

LabelerGLENMARK PHARMACEUTICALS INC., USA
Application holderCEDIPROF INC
FDA applicationANDA210754 (ANDA)
Labeler code68462
First marketedMay 2025
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio343 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 DEXTROAMP-AMPHETAMINE 5 MG TAB 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 orange / white
ShapeRound
ImprintNP008;10
Size9 mm
ScoringScored — splits in 2
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 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 PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • 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.

6 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 DailyMed — ingredient 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 $0.264 $26.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.4441 $44.41 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.5376 $53.76 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.266 $0.239
▲ Up 4% over the last 9 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, dextroamphetamine sulfate, and amphetamine sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 16714-0802-01 Northstar 100 tablets $0.189 AB FDA listed save 28%
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 00185-2098-01 Sandoz 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 00406-8891-01 SpecGx 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 00527-0760-37 Lannett 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 00555-0971-02 Teva 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 11534-0190-01 SUNRISE 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 13107-0068-01 Aurolife 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 16714-0948-01 NorthStar 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 31722-0155-01 Camber 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 42806-0339-01 Epic 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 42858-0721-01 Rhodes 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 47781-0174-01 Alvogen 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 64850-0500-01 Elite 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mgthis 68462-0647-01 GLENMARK 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 70010-0111-01 Granules 100 tablets $0.264 AB Availability likely —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 72516-0016-01 Oryza 100 tablets $0.264 AB Availability likely —
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 57664-0641-08 Sun 100 tablets $0.295 AB FDA listed +12%
Adderall 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 57844-0105-01 Teva 100 tablets $12.243 AB Availability likely +4538%
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 55466-0129-12 Neolpharma, 100 tablets — AB Discontinued —
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 1.25 mg/1; 1.25 mg/1; 1.25 mg/1; 1.25 mg 72162-2048-01 Bryant 100 tablets — AB Discontinued —
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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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 68462-0647-01, 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.
📅 Q2 2025 – Q4 2025 · 3 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
7.7K
Units reimbursed last 4 qtrs
302.9K
Gross reimbursed last 4 qtrs
$134.5K
Avg / prescription
$17.39
Avg / unit
$0.4441
Latest quarter Q4 2025
4KRx
Medicaid pays / ea
$0.4441
gross reimbursed
vs
NADAC / ea
$0.2640
acquisition cost
=
Spread
+$0.1801
+68% 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 ⓘ
49% FFS 51% MCO
Fee-for-service · 3,778 Rx Managed care · 3,958 Rx
State Medicaid map
Alaska: no data reported AK Maine: 12,772 units · 916 per 100k residents ME Washington: 2,519 units · 32.2 per 100k residents WA Idaho: 2,449 units · 125 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 12,487 units · 218 per 100k residents MN Wisconsin: 3,628 units · 61.4 per 100k residents WI Michigan: 6,384 units · 63.6 per 100k residents MI New York: 26,433 units · 135 per 100k residents NY Vermont: 4,001 units · 618 per 100k residents VT New Hampshire: 1,028 units · 73.3 per 100k residents NH Oregon: 925 units · 21.9 per 100k residents OR Nevada: 834 units · 26.1 per 100k residents NV Wyoming: 450 units · 77.1 per 100k residents WY South Dakota: no data reported SD Iowa: 3,089 units · 96.3 per 100k residents IA Illinois: 13,052 units · 104 per 100k residents IL Indiana: no data reported IN Ohio: 5,039 units · 42.8 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 3,724 units · 40.1 per 100k residents NJ Massachusetts: 7,567 units · 108 per 100k residents MA California: 26,654 units · 68.4 per 100k residents CA Utah: 3,395 units · 99.4 per 100k residents UT Colorado: 26,503 units · 451 per 100k residents CO Nebraska: 5,565 units · 281 per 100k residents NE Missouri: 5,959 units · 96.2 per 100k residents MO Kentucky: 14,045 units · 310 per 100k residents KY West Virginia: 5,262 units · 297 per 100k residents WV Virginia: 3,494 units · 40.1 per 100k residents VA Maryland: 6,285 units · 102 per 100k residents MD Connecticut: 5,935 units · 164 per 100k residents CT Rhode Island: 4,593 units · 419 per 100k residents RI Arizona: 16,114 units · 217 per 100k residents AZ New Mexico: 9,626 units · 455 per 100k residents NM Kansas: 1,080 units · 36.7 per 100k residents KS Arkansas: 524 units · 17.1 per 100k residents AR Tennessee: 6,968 units · 97.8 per 100k residents TN North Carolina: 10,741 units · 99.1 per 100k residents NC South Carolina: 2,160 units · 40.2 per 100k residents SC Delaware: no data reported DE Oklahoma: 4,141 units · 102 per 100k residents OK Louisiana: 9,963 units · 218 per 100k residents LA Mississippi: 3,401 units · 116 per 100k residents MS Alabama: 5,180 units · 101 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: 1,533 units · 107 per 100k residents HI Texas: no data reported TX Florida: 17,408 units · 77.0 per 100k residents FL
Units reimbursed · per 100k residents
17.1916
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 Maine 916 /100k
2 Vermont 618 /100k
3 New Mexico 455 /100k
4 Colorado 451 /100k
5 Rhode Island 419 /100k
6 Kentucky 310 /100k
7 West Virginia 297 /100k
8 Nebraska 281 /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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68462-0647-01 You're viewing this 100 TABLET in 1 BOTTLE (68462-647-01) 2025-05-12 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 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🚨 Boxed Warning 162 words ▾

WARNINGS: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 202 words ▾

INDICATIONS AND USAGE Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are 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. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy. Prior to treating patients with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (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 81 words ▾

CONTRAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. 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 ~2 min read ▾

WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have a high potential for abuse and misuse. The use of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets expose individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to anyone else. Throughout dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets-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, consideration discontinuing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss…

🤒 Adverse Reactions 110 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, 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.

🆘 Overdosage 99 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 Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have 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 i…

📦 How Supplied / Storage and Handling ~1 min read ▾

HOW SUPPLIED Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as follows: 5 mg: A white to off white, round, biconvex quadrisect tablet debossed on one side with “5” in the upper left quadrant. The other side is quadrisected and debossed with NP007. Bottles of 100 Tablets NDC 68462-647-01 10 mg: A white to off white, round, biconvex quadrisect tablet debossed on one side with “10” separated by a bisect in the upper quadrant.

The other side is quadrisected and debossed with NP008. Bottles of 100 Tablets NDC 68462-649-01 15 mg: An orange, round, biconvex quadrisect tablet debossed on one side with “15” separated by a bisect in the upper quadrant. The other side is quadrisected and debossed with NP009.

Bottles of 100 Tablets NDC 68462-651-01 20 mg: An orange, round, biconvex quadrisect tablet debossed on one side with “20” separated by a bisect in the upper quadrant. The other side is quadrisected and debossed with NP010. Bottles of 100 Tablets NDC 68462-652-01 30 mg: An orange, round, biconvex quadrisect tablet debossed on one side with “30” separated by a bisect in the upper quadrant.

The other side is quadrisected and debossed with NP011. Bottles of 100 Tablets NDC 68462-653-01 Dispense in a tight, light-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Distributed by: Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 August 2025 PP64702 glenmarklogo

📋 Description 140 words ▾

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 monohydrate. EACH TABLET CONTAINS 5 mg 10 mg 15 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Dextroamphetamine Sulfate, USP 1.25 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 2.5 mg 3.75 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 6.3 mg 9.4 mg 12.6 mg 18.8 mg Inactive Ingredients: microcrystalline cellulose, maltodextrin, compressible sugar, corn starch, colloidal silicon dioxide, saccharin sodium and magnesium stearate.

The 15 mg, 20 mg and 30 mg tablets contain FD&C Yellow #6 Aluminum Lake as a color additive.

💬 Medication Guide ~2 min read ▾

MEDICATION GUIDE MEDICATION GUIDE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII (DEX-troe-am-FET-uh-meen SACK-uh-rate, am-FET-uh-meen ass-PAR-tate, DEX-troe-am-FET-uh-meen SULL-fate, am-FET-uh-meen SULL-fate) What is the most important information I should know about dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets? Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may cause serious side effects, including: • Abuse, misuse, and addiction .

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets and will monitor you or your child during treatment. • Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. • Do not give dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets to anyone else.

See "What is dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets?” for more information. • Keep dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets in a safe place and properly dispose of any unused medicine. See " How should I store dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets? " 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. • 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets. • 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…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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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.