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Linzess linaclotide 145 ug Capsule, Gelatin Coated, 4-count — NDC 00456-1201-04 package photo

Linzess linaclotide 145 ug Capsule, Gelatin Coated, 4-count

by Allergan, Inc. · 1 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE
NDC 00456-1201-04
🏷️ FDA NDC (as labeled) 0456-1201-04 billing pads the labeler segment with a zero
This package
Contains4-count Pack sizes3 compare ↓
Also priced by: Part D plans $9.01/unit — full pricing hub ↓
Also comes in: 7 capsules 00456-1201-07 30 capsules 00456-1201-30
Rx only 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) 0456-1201-04
Product NDC 0456-1201
11-digit billing NDC 00456120104
RxCUI 1307409, 1307415, 1307419, 1307421, 1869697, 1869699
UNII N0TXR0XR5X
UPC 0304561203307, 0304561202300, 0304561201303
Application # NDA202811
SPL Set ID 09beda19-56d6-4a56-afdc-9a77b70b2ef3
Established class (EPC) Guanylate Cyclase-C Agonist
Mechanism of action Guanylate Cyclase Activators
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-09-08
Route ORAL
Dosage form CAPSULE, GELATIN COATED
Substance LINACLOTIDE
GPI-14 52557050000120
GPI class Linzess
GCN Seq No 069922
GCN 33187
HICL code 039583
Ingredient (HICL) Linaclotide
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D6
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Colon
HIC3 code D6G
Therapeutic class — specific (HIC3) Ibs-C/Cic Agents, Guanylate Cyclase-C Agonist
AHFS code 56:18.12.00
AHFS class Guanylate Cyclase C (Gcc) Recept Agonist
FDB label name LINZESS 145 MCG CAPSULE
FDB brand name Linzess
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0456-1201-04 — 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 → 00456-1201-04. 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 Guanylate Cyclase-C Agonist class.

Pharmacologic class Guanylate Cyclase-C Agonist
Drug family (ATC) Other drugs for constipation
How it works Guanylate Cyclase Activators
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

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA202811 (NDA)
Labeler code00456
First marketedSep 2012
Product typeHuman Prescription Drug
Portfolio188 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 LINZESS 145 MCG CAPSULE Ingredient Linaclotide
📖 What it is MedlinePlus · NLM

Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools). It is also used to treat certain types of constipation in adults and children 6 years of age and older. Linaclotide is in a class of medications called guanylate cyclase-C agonists. It works by increasing the movement of food and waste through the stomach and intestines.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Linzess works directly in your intestine to increase fluid, soften stool, and speed up how quickly things move through. You may notice looser, more frequent stools within the first...
  • What exactly does Linzess do, and how long before it starts working?
  • Take it on an empty stomach, at least 30 minutes before your first meal of the day — and try to take it at the same time each day. If you take it right after a high-fat meal, you'r...
  • Should I take Linzess with food or on an empty stomach?
📖 Read our full Linaclotide 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
ShapeCapsule
ImprintFL;290
Size18 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 M4I0D6VV5M
    Calcium chloride is a salt compound that acts as a firming agent and source of calcium ions in medications. It's used in formulations to help maintain tablet structure, improve texture, or serve as a buffering agent.
  • 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 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII GMW67QNF9C
    Leucine is an amino acid derived from natural sources. It acts as a glidant and flow agent in powders and tablets, helping the medicine move smoothly during manufacturing and packaging.
  • 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.

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 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 · Q2 2026 $9.01 $36.02 / 4 capsules
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
Linzess 145 ugthis 00456-1201-04 Allergan, 4 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

🏛️
2017
First FDA approval
Jan 2017
📍
2026
Currently FDA-listed
9 years listed
🛡️
2034
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2034. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 25, 2017 RLD RS ⏳ ~7.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 7304036 — drug substance (U-1278)
US 9708371 — method of use (U-1515)
US 7304036 — drug substance (U-1278)
US 9708371 — method of use (U-1515)
US 9708371 — method of use (U-1516)
US 8748573 — method of use (U-1516)
US 8748573 — method of use (U-1515)
US 7304036 — drug substance (U-1516)
US 8748573 — method of use (U-1516)
US 7304036 — drug substance (U-1516)
US 8933030 — method of use (U-1516)
US 9708371 — method of use (U-1516)
US 8748573 — method of use (U-1515)
US 10702576 — method of use (U-1516)
US 9708371 — method of use (U-3644)
US 8933030 — method of use (U-3644)
US 10702576 — method of use (U-3644)
US 7304036 — drug substance (U-3644)
US 7304036 — drug substance (U-4345)
US 8933030 — method of use (U-4345)
US 9708371 — method of use (U-4345)
US 8748573 — method of use (U-4345)
US 7304036 — drug substance (U-1516)
US 10702576 — method of use (U-4566)
US 9708371 — method of use (U-4566)
US 8933030 — method of use (U-4566)
US 7304036 — drug substance (U-4566)
US 8933030 — drug product
US 8802628 — drug product
US 10675325 — drug product
US 8802628 — drug product
US 8802628*PED — drug product
US 8802628*PED — drug product
US 7304036*PED — drug product
US 7304036*PED — drug product
US 8748573*PED — drug product
US 8748573*PED — drug product
US 9708371*PED — drug product
US 9708371*PED — drug product
US 9708371*PED — drug product
US 8933030*PED — drug product
US 8933030*PED — drug product
US 7304036*PED — drug product
US 8933030*PED — drug product
US 10675325*PED — drug product
US 10702576*PED — drug product
Exclusivity I-921
Exclusivity NPP
Exclusivity I-921
Exclusivity NPP
Exclusivity PED
2017 2019 2021 2023 2025 2027 2029 2031 2033
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (46)
PatentTypeUse codeExpires
US 7304036 ↗ Drug substance U-1278 Aug 30, 2026
US 9708371 ↗ Method of use U-1515 Aug 16, 2033
US 7304036 ↗ Drug substance U-1278 Aug 30, 2026
US 9708371 ↗ Method of use U-1515 Aug 16, 2033
US 9708371 ↗ Method of use U-1516 Aug 16, 2033
US 8748573 ↗ Method of use U-1516 Oct 30, 2031
US 8748573 ↗ Method of use U-1515 Oct 30, 2031
US 7304036 ↗ Drug substance U-1516 Aug 30, 2026
US 8748573 ↗ Method of use U-1516 Oct 30, 2031
US 7304036 ↗ Drug substance U-1516 Aug 30, 2026
US 8933030 ↗ Method of use U-1516 Feb 17, 2031
US 9708371 ↗ Method of use U-1516 Aug 16, 2033
US 8748573 ↗ Method of use U-1515 Oct 30, 2031
US 10702576 ↗ Method of use U-1516 Aug 11, 2031
US 9708371 ↗ Method of use U-3644 Aug 16, 2033
US 8933030 ↗ Method of use U-3644 Feb 17, 2031
US 10702576 ↗ Method of use U-3644 Aug 11, 2031
US 7304036 ↗ Drug substance U-3644 Aug 30, 2026
US 7304036 ↗ Drug substance U-4345 Aug 30, 2026
US 8933030 ↗ Method of use U-4345 Feb 17, 2031
US 9708371 ↗ Method of use U-4345 Aug 16, 2033
US 8748573 ↗ Method of use U-4345 Oct 30, 2031
US 7304036 ↗ Drug substance U-1516 Aug 30, 2026
US 10702576 ↗ Method of use U-4566 Aug 11, 2031
US 9708371 ↗ Method of use U-4566 Aug 16, 2033
US 8933030 ↗ Method of use U-4566 Feb 17, 2031
US 7304036 ↗ Drug substance U-4566 Aug 30, 2026
US 8933030 ↗ Drug product — Feb 17, 2031
US 8802628 ↗ Drug product — Oct 30, 2031
US 10675325 ↗ Drug product — Aug 11, 2031
US 8802628 ↗ Drug product — Oct 30, 2031
US 8802628*PED ↗ Drug product — Apr 30, 2032
US 8802628*PED ↗ Drug product — Apr 30, 2032
US 7304036*PED ↗ Drug product — Feb 28, 2027
US 7304036*PED ↗ Drug product — Feb 28, 2027
US 8748573*PED ↗ Drug product — Apr 30, 2032
US 8748573*PED ↗ Drug product — Apr 30, 2032
US 9708371*PED ↗ Drug product — Feb 16, 2034
US 9708371*PED ↗ Drug product — Feb 16, 2034
US 9708371*PED ↗ Drug product — Feb 16, 2034
US 8933030*PED ↗ Drug product — Aug 17, 2031
US 8933030*PED ↗ Drug product — Aug 17, 2031
US 7304036*PED ↗ Drug product — Feb 28, 2027
US 8933030*PED ↗ Drug product — Aug 17, 2031
US 10675325*PED ↗ Drug product — Feb 11, 2032
US 10702576*PED ↗ Drug product — Feb 11, 2032
FDA exclusivity
CodeWhat it grantsExpires
I-921New indication (3-year)Jun 12, 2026
NPPNew Patient PopulationNov 4, 2028
I-921New indication (3-year)Jun 12, 2026
NPPNew Patient PopulationMay 21, 2029
PEDPediatric Exclusivity (+6 months)May 4, 2029
Common questions
Is there a generic version of LINZESS 145 MCG CAPSULE?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for LINZESS 145 MCG CAPSULE. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Feb 2034 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 capsules00456-1201-30 406,155 Rx · $234,762,679
4 capsules this page00456-1201-04 No Medicaid data
7 capsules00456-1201-07 No Medicaid data
Drug total (last 4 qtrs): 406,155 Rx · 14,326,290 units · $234,762,679 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Linzess — 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 Linzess. 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
$288.29M
Claims incl. refills
670.5K
Beneficiaries
403.5K
Spend / beneficiary
$714.42
Spend / claim
$429.99
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00456-1201-04 You're viewing this 1 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE — — 2012-09-08 Active
00456-1201-30 1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE $9.02 / ea $270.60 2012-09-08 Active
00456-1201-07 1 BOTTLE in 1 CARTON (0456-1201-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE — — 2019-05-17 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00456-1201-04?
NDC 00456-1201-04 is a 4-count package — 1 bottle in 1 carton / 4 capsule, gelatin coated in 1 bottle.
What is the difference between NDC 00456-1201-04 and NDC 00456-1201-07?
Both are Linzess linaclotide 145 ug Capsule, Gelatin Coated — the drug itself is identical. NDC 00456-1201-04 is the 4-count package, while NDC 00456-1201-07 is the 7 capsules package.
What NDC number is used to bill for this package of Linzess linaclotide 145 ug Capsule, Gelatin Coated?
Bill NDC 00456-1201-04 — the 11-digit billing format is 00456120104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription 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 ✓ Available
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 0456-1201-04, 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: 00456-1201-04, written without dashes as 00456120104. 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 00456-1201-04, the first segment (00456) is the labeler code FDA assigned to Allergan, Inc.; the middle segment (1201) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) 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 Allergan, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 7 capsules (00456-1201-07), 30 capsules (00456-1201-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Allergan, Inc. 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?
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📄 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning 114 words ▾

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE LINZESS is contraindicated in patients less than 2 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )]. WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE See full prescribing information for complete boxed warning.

LINZESS is contraindicated in patients less than 2 years of age; in neonatal mice, linaclotide caused deaths due to dehydration. ( 4 , 5.1 , 8.4 )

🎯 Indications and Usage 103 words ▾

1 INDICATIONS AND USAGE LINZESS is indicated for the treatment of: • irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older • chronic idiopathic constipation (CIC) in adults • functional constipation (FC) in pediatric patients 2 years of age and older LINZESS is a guanylate cyclase-C agonist indicated for treatment of: Irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. ( 1 ) Chronic idiopathic constipation (CIC) in adults.

( 1 ) Functional constipation (FC) in pediatric patients 2 years of age and older. ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage in adults is: IBS-C : 290 mcg orally once daily. ( 2.1 ) CIC : 145 mcg orally once daily or 72 mcg orally once daily based on individual presentation or tolerability. ( 2.1 ) The recommended dosage in pediatric patients: 7 years of age and older with IBS-C : 145 mcg orally once daily.

( 2.1 ) 2 years of age and older with FC : 72 mcg orally once daily. ( 2.1 ) Administration Instructions ( 2.2 ): Take on empty stomach at least 30 minutes prior to a meal at approximately the same time each day. Do not crush or chew LINZESS capsule or capsule contents.

For patients who have difficulty swallowing capsules whole or those with a nasogastric or gastrostomy tube, see full prescribing information for instructions for opening the capsule and administering with applesauce or water.

2.1Recommended Dosage Irritable Bowel Syndrome with Constipation (IBS-C) : The recommended dosage of LINZESS is: • Adults : 290 mcg orally once daily • Pediatric patients 7 years of age and older : 145 mcg orally once daily Chronic Idiopathic Constipation (CIC) in Adults The recommended dosage of LINZESS in adults is 145 mcg orally once daily. A dosage of 72 mcg once daily may be used based on individual presentation or tolerability. Functional Constipation (FC) in Pediatric Patients 2 Years of Age and Older The recommended dosage of LINZESS in pediatric patients 2 years of age and older is 72 mcg orally once daily.

2.2Preparation and Administration Instructions • Take LINZESS on an empty stomach, at least 30 minutes prior to a meal at approximately the same time each day. • If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take 2 doses at the same time. • Do not crush or chew LINZESS capsule or capsule contents. • Swallow LINZESS capsule whole. • For patients who are unable to swallow the capsule whole, LINZESS capsules can be opened and administered orally in either applesauce or with water or administered with water via a nasogastric or gastrostomy tube.

Sprinkling of LINZESS beads on other soft foods or in other liquids has not been tested. Oral Administration in Applesauce Place one teaspoonful of room-temperature applesauce into a clean container. Open the capsule.

Sprinkle the entire contents (beads) on applesauce. Consume the entire contents immediately. Do not chew the beads.

Do not store the bead-applesauce mixture for later use. Oral Administration in Water Pour approximately 30 mL of room-temperature bottled water into a clean cup. Open the capsule.

Sprinkle the entire contents (beads) into the water. Gently swirl beads and water for at least 20 seconds. Swallow the entire mixture of beads and water immediately.

Add another 30 mL of water to any beads remaining in cup, swirl for 20 seconds, and swallow immediately. Do not store the bead-water mixture for later use. Note: The drug is coated on the surface of the beads and will dissolve off the beads into the water.

The beads will remain visible and will not dissolve. Therefore, it is not necessary to consume all the beads to deliver the complete dose. Administration with Water via a Nasogastric or Gastrostomy Tube Open the capsule and empty the beads into a clean container with 30 mL of room-temperature bottled water.

Mix by gently swirling beads for at least 20 seconds. Draw-up the beads and water mixture into an appropriately sized catheter-tipped syringe and apply rapid and steady pressure (10 mL/10 seconds) to dispense the syringe contents into the tube. Add another 30 mL of water to any beads remaining in the container and repeat the process.

After administering the bead-water mixture, flush nasogastric/ gastrostomy tube with a minimum of 10 mL of water. Note: It is not necessary to flush all the beads through to deliver the complete dose.

💊 Dosage Forms and Strengths 41 words ▾

3 DOSAGE FORMS AND STRENGTHS LINZESS capsules are white to off-white opaque: 72 mcg; gray imprint “FL 72” 145 mcg; gray imprint “FL 145” 290 mcg; gray imprint “FL 290” Capsules: 72 mcg, 145 mcg and 290 mcg ( 3 )

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS LINZESS is contraindicated in: Patients less than 2 years of age due to the risk of serious dehydration [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] . Patients with known or suspected mechanical gastrointestinal obstruction. Patients less than 2 years of age. ( 4 , 5.1 , 8.4 ) Patients with known or suspected mechanical gastrointestinal obstruction. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Diarrhea: Patients may experience severe diarrhea. If severe diarrhea occurs, suspend dosing and rehydrate the patient. ( 5.2 )

5.1Risk of Serious Dehydration in Pediatric Patients Less Than 2 Years of Age LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice (human age equivalent of approximately 0 to 28 days), linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism which was associated with increased mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.4 ) ] .

5. 2 Diarrhea In adults, diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar between the IBS-C and CIC populations.

Severe diarrhea was reported in 2% of adult patients with IBS-C or CIC treated with LINZESS 145 mcg or 290 mcg once daily, and in <1% of adult patients with CIC treated with LINZESS 72 mcg once daily [see Adverse Reactions ( 6.1 )] . In pediatric patients, diarrhea was also the most common adverse reaction in clinical trials of patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC treated with LINZESS [see Adverse Reactions ( 6.1 )]. • In a double-blind trial of patients 7 to 17 years of age with IBS-C, diarrhea was reported in 7% and 8% of patients treated with LINZESS 145 mcg and 290 mcg once daily, respectively.

One severe case of diarrhea was reported in the IBS-C trial at a dosage higher than the recommended LINZESS 145 mcg once daily dosage for IBS-C. • In a double-blind trial of patients 6 to 17 years of age with FC treated with LINZESS 72 mcg once daily, diarrhea was reported in 4% of patients, and one case of severe diarrhea was reported. In post-marketing experience, severe diarrhea associated with dizziness, syncope, hypotension and electrolyte abnormalities (hypokalemia and hyponatremia) requiring hospitalization or intravenous fluid administration have been reported in patients treated with LINZESS.

If severe diarrhea occurs, suspend dosing and rehydrate the patient.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥2%) reported in adult patients with IBS-C or CIC are: diarrhea, abdominal pain, flatulence and abdominal distension. ( 6.1 ) Most common adverse reaction (≥2%) reported in pediatric patients 7 to 17 years of age with IBS-C and 6 to 17 years of age with FC is diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie, Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Demographic characteristics were comparable between treatment groups in all studies [see Clinical Studies ( 14.1 , 14.2 , 14.3 , 14.4 , 14.5 )] . Irritable Bowel Syndrome with Constipation (IBS-C) in Adults Most Common Adverse Reactions The data described below reflect exposure to LINZESS in the two placebo-controlled clinical trials involving 1605 adult patients with IBS-C (Trials 1 and 2) [see Clinical Studies ( 14.1 )] .

Patients were randomized to receive placebo or 290 mcg LINZESS once daily on an empty stomach for up to 26 weeks. Table 1 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients in the LINZESS treatment group and at an incidence that was greater than in the placebo group. Table 1: Most Common Adverse Reactions a in Two Placebo-Controlled Trials (1 and 2) in Adult Patients with IBS-C Adverse Reactions LINZESS 290 mcg [N=807] % Placebo [N=798] % Gastrointestinal Diarrhea Abdominal pain b Flatulence Abdominal distension 20 7 4 2 3 5 2 1 Infections and Infestations Viral Gastroenteritis 3 1 Nervous System Disorders Headache 4 3 a: Reported in at least 2% of LINZESS-treated patients and at an incidence greater than placebo b: “Abdominal pain” term includes abdominal pain, upper abdominal pain, and lower abdominal pain.

Adverse reactions in an additional placebo-controlled trial in 614 IBS-C patients randomized to placebo or LINZESS 290 mcg once daily on an empty stomach for 12 weeks (Trial 6) were similar to those in Table 1. Diarrhea Diarrhea was the most commonly reported adverse reaction of the LINZESS-treated patients in the pooled IBS-C pivotal placebo-controlled trials. In these trials, 20% of LINZESS-treated patients reported diarrhea compared to 3% of placebo-treated patients.

Severe diarrhea was reported in 2% of the LINZESS-treated patients versus less than 1% of the placebo-treated patients, and 5% of LINZESS-treated patients discontinued due to diarrhea vs less than 1% of placebo-treated patients. The majority of reported cases of diarrhea started within the first 2 weeks of LINZESS treatment [see Warnings and Precautions ( 5.2 )] . Adverse Reactions Leading to Discontinuation In placebo-controlled trials in patients with IBS-C, 9% of patients treated with LINZESS and 3% of patients treated with placebo discontinued prematurely due to adverse reactions.

In the LINZESS-treatment group, the most common reasons for discontinuation due to adverse reactions were diarrhea (5%) and abdominal pain (1%). In comparison, less than 1% of patients in the placebo group withdrew due to diarrhea or abdominal pain. Adverse Reactions Leading to Dose Reductions In the open-label, long-term trials, 2147 patients with IBS-C received 290 mcg of LINZESS daily for up to 18 months.

In these trials, 29% of patients had their dose reduced or suspended secondary to adverse reactions, the majority of which were diarrhea or other GI adverse reactions. Less Common Adverse Reactions Defecation urgency, fecal incontinence, vomiting, and gastroesophageal reflux disease were reported in <2% of patients in the LINZESS-treatment group and at an incidence greater than in the placebo treatment group. IBS- C in Pediatric Patients 7 Years of Age and Older The safety of LI…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS 8. 1 Pregnancy Risk Summary Linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology ( 12.3 )] , and maternal use is not expected to result in fetal exposure to the drug. The available data on LINZESS use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage.

In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during organogenesis at doses much higher than the maximum recommended human dosage. Severe maternal toxicity associated with effects on fetal morphology were observed in mice ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data The potential for linaclotide to cause harm to embryo-fetal development was studied in rats, rabbits and mice.

In pregnant mice, oral dose levels of at least 40,000 mcg/kg/day given during organogenesis produced severe maternal toxicity including death, reduction of gravid uterine and fetal weights, and effects on fetal morphology. Oral doses of 5,000 mcg/kg/day did not produce maternal toxicity or any adverse effects on embryo-fetal development in mice. Oral administration of up to 100,000 mcg/kg/day in rats and 40,000 mcg/kg/day in rabbits during organogenesis produced no maternal toxicity and no effects on embryo-fetal development.

Additionally, oral administration of up to 100,000 mcg/kg/day in rats during organogenesis through lactation produced no developmental abnormalities or effects on growth, learning and memory, or fertility in the offspring through maturation. The maximum recommended human dose is approximately 5 mcg/kg/day, based on a 60-kg body weight. Limited systemic exposure to linaclotide was achieved in animals during organogenesis (AUC = 40, 640, and 25 ng•hr/mL in rats, rabbits, and mice, respectively, at the highest dose levels).

Linaclotide and its active metabolite are not measurable in human plasma following administration of the recommended clinical dosages. Therefore, animal and human doses should not be compared directly for evaluating relative exposure.

8.2Lactation Risk Summary Linaclotide and its active metabolite were not detected in the milk of lactating women (see Data). In adults, concentrations of linaclotide and its active metabolite were below the limit of quantitation in plasma following multiple doses of LINZESS [see Clinical Pharmacology ( 12.3 ) ] . Maternal use of LINZESS is not expected to result in exposure to linaclotide or its active metabolite in breastfed infants.

There is no information on the effects of linaclotide or its active metabolite on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LINZESS and any potential adverse effects on the breastfed infant from LINZESS or from the underlying maternal condition. Data Following oral administration of 72 mcg, 145 mcg, or 290 mcg of LINZESS once daily for 3 days to breastfeeding mothers taking linaclotide therapeutically, the concentrations of linaclotide and its metabolite were below the limits of quantitation (<0.25 ng/mL and <1 ng/mL, respectively) in all breast milk samples collected over 24 hours.

8.4Pediatric Use LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. In nonclinical studies, deaths occurred within 24 hours in neonatal mice (human age equivalent of approximately 0 to 28 days) following oral administration of linaclotide which increase…

🤰 Pregnancy ~2 min read ▾

8. 1 Pregnancy Risk Summary Linaclotide and its active metabolite are negligibly absorbed systemically following oral administration [see Clinical Pharmacology ( 12.3 )] , and maternal use is not expected to result in fetal exposure to the drug. The available data on LINZESS use in pregnant women are not sufficient to inform any drug-associated risk for major birth defects and miscarriage.

In animal developmental studies, no effects on embryo-fetal development were observed with oral administration of linaclotide in rats and rabbits during organogenesis at doses much higher than the maximum recommended human dosage. Severe maternal toxicity associated with effects on fetal morphology were observed in mice ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data The potential for linaclotide to cause harm to embryo-fetal development was studied in rats, rabbits and mice.

In pregnant mice, oral dose levels of at least 40,000 mcg/kg/day given during organogenesis produced severe maternal toxicity including death, reduction of gravid uterine and fetal weights, and effects on fetal morphology. Oral doses of 5,000 mcg/kg/day did not produce maternal toxicity or any adverse effects on embryo-fetal development in mice. Oral administration of up to 100,000 mcg/kg/day in rats and 40,000 mcg/kg/day in rabbits during organogenesis produced no maternal toxicity and no effects on embryo-fetal development.

Additionally, oral administration of up to 100,000 mcg/kg/day in rats during organogenesis through lactation produced no developmental abnormalities or effects on growth, learning and memory, or fertility in the offspring through maturation. The maximum recommended human dose is approximately 5 mcg/kg/day, based on a 60-kg body weight. Limited systemic exposure to linaclotide was achieved in animals during organogenesis (AUC = 40, 640, and 25 ng•hr/mL in rats, rabbits, and mice, respectively, at the highest dose levels).

Linaclotide and its active metabolite are not measurable in human plasma following administration of the recommended clinical dosages. Therefore, animal and human doses should not be compared directly for evaluating relative exposure.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration. In nonclinical studies, deaths occurred within 24 hours in neonatal mice (human age equivalent of approximately 0 to 28 days) following oral administration of linaclotide which increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in rapid and severe dehydration (see Juvenile Animal Toxicity Data ) . In a clinical GC-C ontogeny study in children 6 months to less than 18 years of age (N=99) to measure GC-C mRNA expression levels in duodenal and colonic samples to evaluate the risk of diarrhea and severe dehydration due to GC-C agonism, there was insufficient data on GC-C intestinal expression to assess the risk of developing diarrhea and its potentially serious consequences in children less than 2 years of age [see Warnings and Precautions ( 5.1 )] .

Functional Constipation (FC) The safety and effectiveness of LINZESS for the treatment of FC have been established in pediatric patients 2 years of age and older. Use of LINZESS for this indication is supported by evidence from adequate and well-controlled studies in adults and pediatric patients 2 to 17 years of age. The safety of LINZESS in adult and pediatric patients in these clinical studies was similar [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.4 , 14.5 )] .

The safety and effectiveness of LINZESS for the treatment of FC have not been established in pediatric patients less than 2 years of age. Irritable Bowel Syndrome with Constipation (IBS-C) The safety and effectiveness of LINZESS for the treatment of IBS-C have been established in pediatric patients 7 years of age and older. Use of LINZESS for this indication is supported by evidence from adequate and well-controlled studies in adults and pediatric patients 7 to 17 years of age.

The safety of LINZESS in adult and pediatric patients in these clinical studies was similar [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.2 )] . The safety and effectiveness of LINZESS for the treatment of IBS-C have not been established in pediatric patients less than 7 years of age. Juvenile Animal Toxicity Data In toxicology studies in neonatal mice, oral administration of linaclotide at 10 mcg/kg/day caused deaths on post-natal day 7 (human age equivalent of approximately 0 to 28 days).

These deaths were due to rapid and severe dehydration produced by significant fluid shifts into the intestinal lumen resulting from GC-C agonism in neonatal mice [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Tolerability to linaclotide increases with age in juvenile mice. In 2-week-old mice, linaclotide was well tolerated at a dose of 50 mcg/kg/day, but deaths occurred after a single oral dose of 100 mcg/kg.

In 3-week-old mice, linaclotide was well tolerated at 100 mcg/kg/day, but deaths occurred after a single oral dose of 600 mcg/kg.

🧓 Geriatric Use 158 words ▾

8.5Geriatric Use Irritable Bowel Syndrome with Constipation (IBS-C) Of 2219 IBS-C patients in the placebo-controlled clinical studies of LINZESS (Trials 1, 2, and 6), 154 (7%) were 65 years of age and over, while 34 (2%) were 75 years and over. Clinical studies of LINZESS did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Chronic Idiopathic Constipation (CIC) Of 2498 CIC patients in the placebo-controlled clinical studies of LINZESS (Trials 3, 4, and 5), 273 (11%) were 65 years of age and over, while 56 (2%) were 75 years and over.

Clinical studies of LINZESS did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage 38 words ▾

10 OVERDOSAGE Single LINZESS doses of 2897 mcg were administered to 22 healthy subjects; the safety profile in these subjects was consistent with that in the overall LINZESS-treated population, with diarrhea being the most commonly reported adverse reaction.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Linaclotide is structurally related to human guanylin and uroguanylin and functions as a guanylate cyclase-C (GC-C) agonist. Both linaclotide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP).

Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. In animal models, linaclotide has been shown to both accelerate GI transit and reduce intestinal pain. In an animal model of visceral pain, linaclotide reduced abdominal muscle contraction and decreased the activity of pain-sensing nerves by increasing extracellular cGMP.

12.2Pharmacodynamics Food Effect Taking LINZESS immediately after a high fat breakfast resulted in looser stools and a higher stool frequency compared with taking it in the fasted state [see Dosage and Administration ( 2.1 , 2.2 )] . In clinical trials, LINZESS was administered on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day.

12.3Pharmacokinetics Absorption LINZESS is minimally absorbed with negligible systemic availability following oral administration. Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 72 mcg, 145 mcg, or 290 mcg were administered. Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (C max ), and half-life (t ½ ) cannot be calculated.

Food Effect Neither linaclotide nor its active metabolite were detected in the plasma following administration of LINZESS 290 mcg once daily for 7 days both in the non-fed and fed state in healthy subjects. Distribution Given that linaclotide plasma concentrations following recommended oral doses are not measurable, linaclotide is not expected to be distributed to tissues to any clinically relevant extent. Elimination Metabolism Linaclotide is metabolized within the gastrointestinal tract to its principal, active metabolite by loss of the terminal tyrosine moiety.

Both linaclotide and the metabolite are proteolytically degraded within the intestinal lumen to smaller peptides and naturally occurring amino acids. Excretion Active peptide recovery in the stool samples of fed and fasted healthy subjects following administration of LINZESS 290 mcg once daily for seven days averaged about 5% (fasted) and about 3% (fed) and all of it as the active metabolite. Specific Populations Renal and Hepatic Impairment Renal or hepatic impairment is not expected to affect the clearance of linaclotide or the active metabolite because linaclotide metabolism occurs within the gastrointestinal tract and plasma concentrations are not measurable in plasma following administration of the recommended dosage.

Drug Interaction Studies No drug-drug interaction studies have been conducted with LINZESS. Systemic exposures of drug and active metabolite are negligible following oral administration. Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies.

In addition, linaclotide does not interact with common efflux and uptake transporters (including the efflux transporter P-glycoprotein (P-gp)). Based on these in vitro data no drug-drug interactions through modulation of CYP enzymes or common transporters are anticipated.

🧬 Mechanism of Action 133 words ▾

12.1Mechanism of Action Linaclotide is structurally related to human guanylin and uroguanylin and functions as a guanylate cyclase-C (GC-C) agonist. Both linaclotide and its active metabolite bind to GC-C and act locally on the luminal surface of the intestinal epithelium. Activation of GC-C results in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP).

Elevation in intracellular cGMP stimulates secretion of chloride and bicarbonate into the intestinal lumen, mainly through activation of the cystic fibrosis transmembrane conductance regulator (CFTR) ion channel, resulting in increased intestinal fluid and accelerated transit. In animal models, linaclotide has been shown to both accelerate GI transit and reduce intestinal pain. In an animal model of visceral pain, linaclotide reduced abdominal muscle contraction and decreased the activity of pain-sensing nerves by increasing extracellular cGMP.

📦 How Supplied / Storage and Handling 116 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied LINZESS Capsule Strength Description Packaging NDC number 72 mcg White to off-white opaque hard gelatin capsules with gray imprint “FL 72” Bottle of 30 0456-1203-30 145 mcg White to off-white opaque hard gelatin capsules with gray imprint "FL 145" Bottle of 30 0456-1201-30 290 mcg White to off-white opaque hard gelatin capsules with gray imprint "FL 290" Bottle of 30 0456-1202-30 Storage Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Keep LINZESS in the original container. Do not subdivide or repackage. Protect from moisture.

Do not remove desiccant from the container. Keep bottles tightly closed in a dry place.

📋 Description 186 words ▾

11 DESCRIPTION LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C 59 H 79 N 15 O 21 S 6 and its molecular weight is 1526.8.

The amino acid sequence for linaclotide is shown below: Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules.

LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide.

The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide. LINZESS (linaclotide) is a guanylate cyclase-C (G-CC) agonist.

Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide).

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Advise patients: Diarrhea To stop LINZESS and contact their healthcare provider if they experience unusual or severe abdominal pain, and/or severe diarrhea, especially if in combination with hematochezia or melena [see Warnings and Precautions ( 5.2 )] . Accidental Ingestion Accidental ingestion of LINZESS in children especially in patients less than 2 years of age may result in severe diarrhea and dehydration.

Instruct patients to take steps to store LINZESS securely and out of reach of children, and to dispose of unused LINZESS [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 , 5.2 )]. Administration and Handling Instructions To take LINZESS once daily on an empty stomach at least 30 minutes prior to a meal at approximately the same time each day [see Dosage and Administration ( 2.2 )]. If a dose is missed, skip the missed dose and take the next dose at the regular time.

Do not take 2 doses at the same time. To swallow LINZESS capsules whole. Do not crush or chew capsules or capsule contents.

For patients who are unable to swallow the capsule whole, LINZESS capsules can be opened and administered orally in either applesauce or with bottled water or administered with water via a nasogastric or gastrostomy tube, as described in the Medication Guide. To keep LINZESS in the original container. Do not subdivide or repackage.

Protect from moisture. Do not remove desiccant from the container. Keep bottles closed tightly in a dry place .

Marketed by: AbbVie, Inc. North Chicago, IL 60064 Ironwood Pharmaceuticals, Inc. Boston, MA, 02110 © 2026 AbbVie and Ironwood Pharmaceuticals, Inc.

All rights reserved. LINZESS and its design are registered trademarks of Ironwood Pharmaceuticals, Inc. For more information, go to www.LINZESS.com or call 1-800-633-9110.

20101179

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE LINZESS ® (lin-ZESS) (linaclotide) c apsules , for oral use What is the most important information I should know about LINZESS? Do not give LINZESS to children who are less than 2 years of age. It may harm them.

See the section “ What are the possible side effects of LINZESS? ” for more information about side effects. What is LINZESS? LINZESS is a prescription medicine used to treat: irritable bowel syndrome with constipation (IBS-C) in adults and in children and adolescents 7 years of age and older. a type of constipation called chronic idiopathic constipation (CIC) in adults. “Idiopathic” means the cause of the constipation is unknown. functional constipation in children and adolescents 2 years of age and older.

It is not known if LINZESS is safe and effective in children with functional consti p ation less than 2 years of age or in children with I BS-C less than 7 years of age . Who should not take LINZESS? Do not give LINZESS to children who are less than 2 years of age.

LINZESS can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt). Do not take LINZESS if a healthcare provider has told you that you have a bowel blockage (intestinal obstruction). Before you take LINZESS, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if LINZESS will harm your unborn baby. are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take LINZESS and breastfeed. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I take LINZESS? Take LINZESS exactly as your healthcare provider tells you to take it. Take LINZESS 1 time each day on an empty stomach, at least 30 minutes before a meal, at approximately the same time each day.

You should also wait 30 minutes before eating a meal if you take LINZESS with applesauce or mixed with water. If you miss a dose, skip the missed dose. Just take the next dose at your regular time.

Do not take 2 doses at the same time. LINZESS capsules should be swallowed whole. Do not crush or chew LINZESS.

If you cannot swallow LINZESS capsules whole, you may open the LINZESS capsule and sprinkle the LINZESS beads over applesauce or mix LINZESS with bottled water before swallowing. It is not known if LINZESS is safe and effective when sprinkled on other foods or mixed with other liquids. Taking LINZESS in applesauce: Place 1 teaspoon of room temperature applesauce into a clean container.

Open the LINZESS capsule and sprinkle all of the LINZESS beads onto the applesauce. Swallow all of the LINZESS beads and applesauce right away. Do not keep the applesauce for later use.

Do not chew the LINZESS beads. Taking LINZESS in water: Pour 1 ounce (30 mL) of room temperature bottled water into a clean cup. Open the LINZESS capsule and sprinkle all of the LINZESS beads into the cup of water.

Gently swirl the beads and water for at least 20 seconds. Swallow all of the LINZESS beads and water mixture right away. Do not keep the mixture for later use.

If you see any LINZESS beads left in the cup, add another 1 ounce (30 mL) of water to the beads in the cup, swirl for at least 20 seconds, and swallow right away. Taking LINZESS in a nasogastric or gastrostomy feeding tube: Gather the supplies you will need to take your LINZESS dose. Your healthcare provider should tell you what size catheter tipped syringe you will need for your dose.

Ask your healthcare provider if you have any questions about how to give LINZESS the right way. Open the LINZESS capsule and pour all of the LINZESS beads into a clean container with 1 ounce (30 mL) of room temperature bottled water. Gently swirl the beads and water for at least 20 seconds.

Remove the plunger from the catheter tipped syringe, and then pour the LINZESS bead and water mix…

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.