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ALLI orlistat 60 mg Capsule, 2,280-count — NDC 71610-0805-34 package photo

ALLI orlistat 60 mg Capsule, 2,280-count

by Aphena Pharma Solutions - Tennessee, LLC · 2280 CAPSULE in 1 BOTTLE (71610-805-34)
NDC 71610-0805-34
🏷️ FDA NDC (as labeled) 71610-805-34 billing pads the product segment with a zero
OTC Brand On market Non-controlled
🗂️ Data synced Jul 24, 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) 71610-805-34
Product NDC 71610-805
11-digit billing NDC 71610080534
NCPDP billing unit EA — each (per item)
RxCUI 692876, 723846
UNII 95M8R751W8
Application # NDA021887
SPL Set ID 14a75092-f910-53df-e063-6294a90acc66
Established class (EPC) Intestinal Lipase Inhibitor
Mechanism of action Lipase Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2007-02-07
Route ORAL
Dosage form CAPSULE
Substance ORLISTAT
GCN Seq No 062802
GCN 98573
HICL code 018751
Ingredient (HICL) Orlistat
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D5
Therapeutic class — intermediate (HIC2) Acting Primarily On Small Intestine
HIC3 code D5A
Therapeutic class — specific (HIC3) Fat Absorption Decreasing Agents
AHFS code 56:92.00.00
AHFS class Gi Drugs, Miscellaneous
FDB label name ALLI 60 MG CAPSULE
FDB brand name Alli
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 71610-805-34 — 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 → 71610-0805-34. 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 Intestinal Lipase Inhibitor class.

Pharmacologic class Intestinal Lipase Inhibitor
Drug family (ATC) Peripherally acting antiobesity products
How it works Lipase Inhibitors
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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderHALEON US HOLDINGS LLC
FDA applicationNDA021887 (NDA)
Labeler code71610
First marketedFeb 2007
Product typeHuman Otc Drug
Portfolio795 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 ALLI 60 MG CAPSULE Ingredient Orlistat
📖 What it is MedlinePlus · NLM

Orlistat (prescription and nonprescription) is used with an individualized low-calorie, low-fat diet and exercise program to help people lose weight. Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease. Orlistat is also used after weight-loss to help people keep from gaining back that weight. Orlistat is in a class of medications called lipase inhibitors. It works by preventing some of the fat in foods eaten from being absorbed in the intestines. This unabsorbed fat is then removed from the body in the stool.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Orlistat works by blocking some of the fat-digesting enzymes in your stomach and intestines. About 30% of the fat you eat at each meal doesn't get absorbed — it just passes out of...
  • What exactly does orlistat do — and will it really help me lose weight?
  • The oily stools, gas with discharge, and urgent or hard-to-control bowel movements happen because undigested fat has to go somewhere — and it exits in your stool. The more fat you...
  • Why does orlistat cause those embarrassing bathroom side effects, and how do I prevent them?
📖 Read our full Orlistat guide →
5
Nutrient depletion considerations

Orlistat may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Orlistat nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 turquoise / blue
ShapeCapsule
ImprintOrlistat;60
Size15 mm
ScoringNot scored
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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII G7036X8B5H
    A dark iron compound that gives medicine its color. Used as a colorant in tablets and capsules to help identify the medication and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesFD&C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Alli 60 mg 00135-0461-01 Haleon 60 capsules — — FDA listed —
Alli 60 mgthis 71610-0805-34 Aphena 2280 capsules — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2007
On the market since
Feb 2007
📍
2026
Currently FDA-listed
19 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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.

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

Medicare Part D (outpatient prescription) spending for Orlistat (matched by generic name) — 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 Orlistat. CMS lists 2 products for this generic; we show the highest-spend one. 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
$15.5K
Claims incl. refills
20
Beneficiaries
14
Spend / beneficiary
$1,107.53
Spend / claim
$775.27
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 Orlistat — the ingredient across all brands.

Top reported reactions

Rectal Discharge2,434
Gastrointestinal Disorder2,186
Constipation1,991
Diarrhoea1,960
Weight Increased1,944
Steatorrhoea1,649
Flatulence1,619

Age at onset

Neonate9
Infant5
Child4
Adolescent1
Adult199
Elderly32

Reporter sex

25,755 reports
Male · 13%
Female · 87%
Unknown · 0%

Serious outcomes

Disabling322
Death230
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 607 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
71610-0805-34 You're viewing this 2280 CAPSULE in 1 BOTTLE (71610-805-34) 2024-03-22 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71610-805-34, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71610-0805-34, written without dashes as 71610080534. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71610-0805-34, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0805) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (34) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Aphena Pharma Solutions - Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 20 words ▾

Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet

⏱️ Dosage and Administration ~1 min read ▾

Directions read the enclosed brochure for other important information diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program. to see if orlistat capsules are right for you, find your height on the chart to the right.

You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height. for overweight adults 18 years and older: take 1 capsule with each meal containing fat do not take more than 3 capsules daily use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months. if you stop taking orlistat, continue with your diet and exercise program if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program take a multivitamin once a day, at bedtime, when using orlistat Ht. / Wt.

4’10” 129 lbs. 4’11” 133 lbs. 5’0” 138 lbs.

5’1” 143 lbs. 5’2” 147 lbs. 5’3” 152 lbs.

5’4” 157 lbs. 5’5” 162 lbs. 5’6” 167 lbs.

5’7” 172 lbs. 5’8” 177 lbs. 5’9” 182 lbs.

5’10” 188 lbs. 5’11” 193 lbs. 6’0” 199 lbs.

6’1” 204 lbs. 6’2” 210 lbs. 6’3” 216 lbs.

6’4” 221 lbs. 6’5” 227 lbs.

⚠️ Warnings ~2 min read ▾

Warnings Organ transplant alert: do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection. Allergy alert: do not use if you are allergic to any of the ingredients in orlistat capsules Do not use if you are taking cyclosporine if you have been diagnosed with problems absorbing food if you are not overweight Ask a doctor before use if you have ever had gallbladder problems kidney stones pancreatitis Ask a doctor or pharmacist before use if you are taking any of the following prescription medications.

Some prescription doses may need to be adjusted, or some medications may not work as well when used with orlistat. anticoagulants (blood thinning medicine) amiodarone (heart medicine) diabetes medicine thyroid disease medicine seizure medicine antiretrovirals (HIV medicine) taking any other weight loss products When using this product take a multivitamin once a day, at bedtime . Orlistat can reduce the absorption of some vitamins. follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat. orlistat works by preventing the absorption of some of the fat you eat.

The fat passes out of your body, so you may have bowel changes. You may get: gas with oily spotting loose stools more frequent stools that may be hard to control eating a low-fat diet lowers the chance of having these bowel changes for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.

Stop use and ask a doctor if you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat. severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition. you are taking medicine for seizures and your seizures happen more often or get worse If pregnant or breast-feeding, do not use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 29 words ▾

Other information store at 20 - 25 o C (68 - 77 o F) protect drug from excessive light, humidity and temperatures over 30 o C (86 o F)

🧪 Active Ingredient 9 words ▾

Active ingredient (in each sealed capsule) Orlistat 60 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients FD&C Blue No. 2, edible ink, gelatin, iron oxide, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium starch glycolate, talc, titanium dioxide

🎯 Purpose 4 words ▾

Purpose Weight loss aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71610-0804-30 · Aphena 71610-0806-32 · Aphena →
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.