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Lubiprostone 8 ug Capsule, 100-count — NDC 70771-1763-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lubiprostone 8 ug Capsule, 100-count — NDC 70771-1763-1 (Billing 70771-1763-01)

by Zydus Lifesciences Limited · 100 CAPSULE in 1 BOTTLE

This is a package of 100 capsules of Lubiprostone 8 ug Capsule from Zydus Lifesciences Limited, marketed since Mar 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70771-1763-01
🏷️ FDA NDC (as labeled) 70771-1763-1 billing pads the package segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also priced by: Part D plans $1.47/unit — full pricing hub ↓
Main listing for product 70771-1763 · Also comes in: 60 capsules 70771-1763-6
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70771-1763-1
Product NDC 70771-1763
11-digit billing NDC 70771176301
RxCUI 616578, 794639
UNII 7662KG2R6K
Application # ANDA214131
SPL Set ID 81f9c9de-f89d-4ab0-a8ca-18d3691e42f9
Established class (EPC) Chloride Channel Activator
Mechanism of action Chloride Channel Activators
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-03-23
Route ORAL
Dosage form CAPSULE
Substance LUBIPROSTONE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 616578
Why two NDCs? The FDA registers this code as 70771-1763-1 — a 5-4-1 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 package segment → 70771-1763-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Chloride Channel Activator class.

Pharmacologic class Chloride Channel Activator
Drug family (ATC) Other drugs for constipation
How it works Chloride Channel 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.

Clinical

📖 What it is MedlinePlus · NLM

Lubiprostone is used to relieve stomach pain, bloating, and straining and produce softer and more frequent bowel movements in people who have chronic idiopathic constipation (difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Lubiprostone is also 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) in women who are at least 18 years of age. Lubiprostone is also used to treat constipation caused by certain...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats long-lasting constipation with no known cause in adults. It also treats constipation caused by opioid pain medicines in adults with chronic non-cancer pain. In women 18 a...
  • Take your capsule by mouth with food and water, and swallow it whole. Don't chew or break it. It's usually taken twice a day, but follow your prescriber's directions for your dose.
  • Nausea is the most common side effect, and taking it with food may help. Diarrhea, headache, belly pain, bloating, and gas can also happen. Call your doctor if the diarrhea is seve...
  • Call if you faint or feel very lightheaded, or if you get chest tightness or trouble breathing. These can happen within an hour of a dose and may come back with later doses. Severe...
📖 Read our full Lubiprostone 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.

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 $1.47 $147.18 / 100 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70771-1763-01 You're viewing this Main listing 100 CAPSULE in 1 BOTTLE 2023-03-23 — Active
70771-1763-06 70771-1763-6 60 CAPSULE in 1 BOTTLE 2023-03-23 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule in 1 bottle.
How does this package differ from NDC 70771-1763-06?
Both are Lubiprostone 8 ug Capsule — the drug itself is identical. This page's package is the 100-count one, while NDC 70771-1763-06 is the 60 capsules package.
What NDC number is used to bill for this package of Lubiprostone 8 ug Capsule?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lubiprostone 8 ug 00254-3028-02 Par 60 capsules $0.565 AB Availability likely —
Lubiprostone 8 ug 00480-3479-06 Teva 60 capsules $0.565 AB Availability likely —
Lubiprostone .008 mg 31722-0403-60 Camber 60 capsules $0.565 AB Availability likely —
Lubiprostone 8 ug 43598-0163-60 Dr. 60 capsules $0.565 AB Availability likely —
Lubiprostone 8 ug 60687-0816-32 American 1 capsule $0.565 AB Availability likely —
Lubiprostone 8 ug 63304-0351-60 Sun 60 capsules $0.565 AB Availability likely —
Lubiprostone 8 ug 69339-0162-17 Natco 40 capsules $0.565 AB Availability likely —
Lubiprostone .008 mg 72603-0288-01 Northstar 60 capsules $0.565 AB Availability likely —
Lubiprostone 8 ug 65162-0841-06 Amneal 60 capsules $0.716 AB Discontinued —
Amitiza 8 ug 23635-0508-60 SpecGx 60 capsules $6.468 AB Availability likely —
Lubiprostone 8 ug 00406-6408-60 SpecGx 60 capsules — AB FDA listed —
Lubiprostone 8 ug 51407-0744-60 Golden 60 capsules — AB FDA listed —
Lubiprostone 8 ug 70710-1641-01 Zydus 100 capsules — AB FDA listed —
Lubiprostone 8 ugthis 70771-1763-01 Zydus 100 capsules — AB FDA listed —
Lubiprostone 8 ug 71205-0831-00 Proficient 100 capsules — AB FDA listed —
Amitza 8 ug 72189-0410-60 Direct_Rx 60 capsules — AB FDA listed —
Lubiprostone 8 ug 76420-0777-01 Asclemed 100 capsules — AB FDA listed —
Lubiprostone 8 ug 76420-0906-01 Asclemed 100 capsules — AB FDA listed —
Lubiprostone 8 ug 80425-0354-02 Advanced 60 capsules — AB FDA listed —
Amitiza 8 ug 64764-0080-40 Takeda 4 capsules — AB Discontinued —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Mar 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.

What it looks like

Color Pink / Yellow
ShapeOval
Imprint24
Size9 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 AV0YTZ4E6J
    A chemical compound derived from sorbitol, a natural sugar alcohol. It acts as an emulsifier and surfactant to help blend oil and water-based ingredients in medicines, ensuring uniform texture and stability.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product 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 C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 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.

Manufacturer & labeler

LabelerZydus Lifesciences Limited
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA214131 (ANDA)
Labeler code70771
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio717 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.

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 9 words ▾

No readable label sections were found for this product.

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

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

Medicare Part D (outpatient prescription) spending for Lubiprostone — the program that covers self-administered drugs. 8 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 Lubiprostone. 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
$17.94M
Claims incl. refills
147.2K
Beneficiaries
85K
Spend / beneficiary
$211.07
Spend / claim
$121.87
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 Lubiprostone — the ingredient across all brands.

Top reported reactions

Nausea792
Dyspnoea634
Diarrhoea619
Constipation581
Fatigue535
Pain495
Headache492

Age at onset

Neonate1
Infant1
Child3
Adolescent6
Adult601
Elderly711

Reporter sex

9,403 reports
Male · 30%
Female · 70%
Unknown · 0%

Serious outcomes

Hospitalization3,087
Death961
Life-threatening390
Disabling247
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 883 264
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Zydus Lifesciences Limited. 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 1 other package presentation of this same product, including 60 capsules (70771-1763-06). 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?
Zydus Lifesciences Limited 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 a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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.
← 70771-1762-01 · Zydus 70771-1764-01 · Zydus →
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.