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Lisdexamfetamine Dimesylate 60 mg Capsule, 100-count — NDC 0527-4666-37 (Billing 00527-4666-37)

by Lannett Company, LLC · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Lisdexamfetamine Dimesylate 60 mg Capsule from Lannett Company, LLC, marketed since Aug 2023 and currently FDA-listed; retail pharmacies pay about $2.67 per capsule (NADAC). It is this product's only package size.

NDC 00527-4666-37
🏷️ FDA NDC (as labeled) 0527-4666-37 billing pads the labeler segment with a zero
Rx only Generic On market CII ⚠ On shortage ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 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

NDC database record

One package, one record: these facts belong to NDC 0527-4666-37 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0527 labeler · 4666 product · 37 package
Package marketed since
Aug 25, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
100 EA per package
Barcode (UPC-A, from the NDC)
3 0527466637 3
Medicaid fills, this package
2,852 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Active FDA shortage. Lisdexamfetamine Dimesylate Capsule is currently reported in shortage by the FDA. Available Shortage details →
⚠️
Other active recalls for Lisdexamfetamine Dimesylate (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 28, 2025 — Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0149-2026
Class II · Oct 28, 2025 — Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0148-2026
Class II · Oct 28, 2025 — Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0150-2026
Class II · Oct 28, 2025 — Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0145-2026
Class II · Oct 28, 2025 — Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0144-2026
Class II · Oct 28, 2025 — Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0147-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (2)
Class II · Aug 11, 2025 · Terminated — Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained Lisdexamphetamine Dimesylate Capsules 30mg. (Lannett Company Inc.) · FDA recall D-0599-2025
Class II · Oct 25, 2024 · Terminated — Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity. (Lannett Company Inc.) · FDA recall D-0112-2025

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0527-4666-37
Product NDC 0527-4666
11-digit billing NDC 00527466637
NCPDP billing unit EA — each (per item)
Application # ANDA215802
SPL Set ID 164b5658-3c14-44f5-b10a-839909184984
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 2023-08-25
Route ORAL
Dosage form CAPSULE
Substance LISDEXAMFETAMINE DIMESYLATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 063647
GCN 99368
HICL code 034486
Ingredient (HICL) Lisdexamfetamine Dimesylate
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 LISDEXAMFETAMINE 60 MG CAPSULE
FDB brand name Lisdexamfetamine Dimesylate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063647
  • GCN: 99368
  • HICL (First Databank): 034486
  • AHFS class code: 28:20.04.00
Why two NDCs? The FDA registers this code as 0527-4666-37 — a 4-4-2 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 labeler segment → 00527-4666-37. 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.

Clinical

Label name LISDEXAMFETAMINE 60 MG CAPSULE Ingredient Lisdexamfetamine Dimesylate
📖 What it is MedlinePlus · NLM

Lisdexamfetamine is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children 6 years of age and older. Lisdexamfetamine is also used in adults to treat binge eating disorder (an eating disorder characterized by periods of uncontrolled overeating). Lisdexamfetamine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats ADHD in adults and children 6 and older, and moderate to severe binge eating disorder in adults. It is not approved for weight loss, so please don't use it for that.
  • Take it in the morning, with or without food. Afternoon doses can keep you awake. Capsules can be swallowed whole or opened and mixed into yogurt, water or orange juice, then taken...
  • Decreased appetite, trouble sleeping and dry mouth are the most common. Some people also have nausea, anxiety, irritability or a faster heartbeat. Call your doctor for chest pain,...
  • Yes. It has a high potential for abuse and misuse, and that can lead to addiction, overdose and death. Keep it locked up, never share it, and dispose of leftovers properly.
📖 Read our full Lisdexamfetamine 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.

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 $2.673 $267.29 / 100 capsules
Medicaid paysCMS SDUD · 12 mo $4.41 $440.65 / 100 capsules
Medicare drug plans payPart D · Q2 2026 $5.94 $594.36 / 100 capsules
NADAC price history (per ea) — tap or hover for the price & month
Dec 2023 Jan 2026 May 2026 Sep 2026 $6.629 $2.673
▼ Down 28% over the last 13 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00527-4666-37 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2023-08-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lisdexamfetamine Dimesylate 60 mg 00054-0374-25 Hikma 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 00378-6859-77 Mylan 90 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 00406-5116-01 SpecGx 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine dimesylate 60 mg 00480-3570-01 Teva 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mgthis 00527-4666-37 Lannett 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine dimesylate 60 mg 00781-2480-01 Sandoz 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 31722-0355-01 Camber 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 42858-0166-01 Rhodes 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine dimesylate 60 mg 43547-0607-10 Solco 100 capsules $2.673 AB Availability likely —
lisdexamfetamine dimesylate 60 mg 47781-0567-01 Alvogen 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 57664-0051-88 Sun 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 60505-4744-01 Apotex 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 60687-0940-21 American 30 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 64850-0555-01 Elite 100 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 65162-0027-09 Amneal 90 capsules $2.673 AB Availability likely —
Lisdexamfetamine Dimesylate 60 mg 70010-0211-01 Granules 100 capsules $2.673 AB Availability likely —
Vyvanse 60 mg 59417-0106-10 Takeda 100 capsules $12.361 AB Availability likely +362%
Lisdexamfetamine Dimesylate 60 mg 42291-0040-90 AvKARE 90 capsules — AB FDA listed —
Lisdexamfetamine Dimesylate 60 mg 72162-2457-01 Bryant 100 capsules — 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

🏛️
2023
On the market since
Aug 2023
📍
2026
Currently FDA-listed
3 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.

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.

🧪 Avoiding an ingredient? See Lisdexamfetamine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerLannett Company, LLC
Application holderLANNETT CO INC
FDA applicationANDA215802 (ANDA)
Labeler code00527
First marketedAug 2023
DEA scheduleCII
Product typeHuman Prescription Drug
Portfolio30 products on file

More NDCs from Lannett Company, LLC labeler code 00527

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.

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.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

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

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 this package alone, 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 – Q1 2026 · 5 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
2.9K
Units reimbursed last 4 qtrs
83.7K
Gross reimbursed last 4 qtrs
$368.9K
Avg / prescription
$129.33
Avg / unit
$4.4065
Latest quarter Q1 2026
648Rx
Medicaid pays / ea
$4.4065
gross reimbursed
vs
NADAC / ea
$2.6729
acquisition cost
=
Spread
+$1.7336
+65% 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 ⓘ
93% MCO
Fee-for-service · 188 Rx Managed care · 2,664 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 712 units · 9.1 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 5,649 units · 98.5 per 100k residents MN Wisconsin: no data reported WI Michigan: 810 units · 8.1 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 464 units · 50.5 per 100k residents SD Iowa: 5,209 units · 162 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 24,843 units · 192 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 358 units · 18.1 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,283 units · 14.7 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 1,358 units · 46.2 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 3,143 units · 68.7 per 100k residents LA Mississippi: 1,170 units · 39.8 per 100k residents MS Alabama: 2,578 units · 50.5 per 100k residents AL Georgia: 760 units · 6.9 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 35,372 units · 116 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
6.9192
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 Pennsylvania 192 /100k
2 Iowa 162 /100k
3 Texas 116 /100k
4 Minnesota 98.5 /100k
5 Louisiana 68.7 /100k
6 South Dakota 50.5 /100k
7 Alabama 50.5 /100k
8 Kansas 46.2 /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 Lisdexamfetamine Dimesylate — the program that covers self-administered drugs. 18 manufacturers.
⚠️ 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 Lisdexamfetamine Dimesylate. 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
$19.32M
Claims incl. refills
112.5K
Beneficiaries
50K
Spend / beneficiary
$386.28
Spend / claim
$171.66
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.
← 00527-4665-37 · Lannett 00527-4667-37 · Lannett →
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.