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Tadalafil 20 mg Tablet, Film Coated, 30-count

by Macleods Pharmaceuticals Limited · 30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07)

NDC 33342-0278-07

🏷️ FDA NDC (as labeled) 33342-278-07 billing pads the product segment with a zero

This package

Contains30-count Pack sizes2 compare ↓

Also priced by: Part D plans $1.27/unit — full pricing hub ↓

Also comes in: 60 tablets 33342-0278-09

Rx only Generic 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 Dr. Brian Staiger, PharmD

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

⚠️

Other active recalls for Tadalafil (different manufacturers) — 3 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 23, 2023 — cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. (Preferred Pharmaceuticals, Inc.) · FDA recall D-0526-2023

Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0553-2023

Class II · Mar 16, 2023 — CGMP Deviations (Northwind Pharmaceuticals LLC) · FDA recall D-0554-2023

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 33342-278-07

Product NDC 33342-278

11-digit billing NDC 33342027807

RxCUI 2123194

UNII 742SXX0ICT

Application # ANDA207290

SPL Set ID 93dd604f-8f38-4600-afe8-0fcc92fd2497

Established class (EPC) Phosphodiesterase 5 Inhibitor

Mechanism of action Phosphodiesterase 5 Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-10-17

Route ORAL

Dosage form TABLET, FILM COATED

Substance TADALAFIL

GPI-14 40143080000320

GPI class Tadalafil (PAH)

GCN Seq No 065368

GCN 26587

HICL code 024859

Ingredient (HICL) Tadalafil

HIC1 code B

Therapeutic class — broad (HIC1) Respiratory System

HIC2 code B1

Therapeutic class — intermediate (HIC2) Affect Primarily Lungs

HIC3 code B1D

Therapeutic class — specific (HIC3) Pulm.anti-Htn,Sel.c-Gmp Phosphodiesterase T5 Inhib

AHFS code 24:08.12.00

AHFS class Phosphodiesterase Type 5 Inhibitors

FDB label name TADALAFIL 20 MG TABLET

FDB brand name Tadalafil

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB2 · RLD · RS

Why two NDCs? The FDA registers this code as 33342-278-07 — 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 → 33342-0278-07. 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 Phosphodiesterase 5 Inhibitor class.

Pharmacologic class Phosphodiesterase 5 Inhibitor

Drug family (ATC) Testosterone-5-alpha reductase inhibitors, Antihypertensives for pulmonary arterial hypertension, Drugs used in erectile dysfunction

How it works Phosphodiesterase 5 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

LabelerMacleods Pharmaceuticals Limited

Application holderMACLEODS PHARMACEUTICALS LTD

FDA applicationANDA207290 (ANDA)

Labeler code33342

First marketedOct 2019

Product typeHuman Prescription Drug

Portfolio385 products on file

🔎 All NDCs from Macleods Pharmaceuticals Limited

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 TADALAFIL 20 MG TABLET Ingredient Tadalafil

📖 What it is MedlinePlus · NLM

Tadalafil (Cialis) is used to treat erectile dysfunction (ED, impotence; inability to get or keep an erection), and the symptoms of benign prostatic hyperplasia (BPH; an enlarged prostate) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency in adult men. Tadalafil (Adcirca) is used to improve the ability to exercise in people with pulmonary arterial hypertension (PAH; high blood pressure in the vessels carrying blood to the lungs, causing shortness of breath, dizziness, and tiredness). Ta...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Tadalafil is the active ingredient in several branded products, each approved for a specific use. Cialis (and generic tadalafil tablets) treat erectile dysfunction, an enlarged pro...
What exactly is tadalafil used for, and why do I see so many different brand names?
It depends on what you're taking it for. For erectile dysfunction, your doctor may prescribe it as-needed — taken before sexual activity — or as a lower once-daily dose so you don'...
Do I take it every day, or just when I need it?

📖 Read our full Tadalafil guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Tadalafil — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Tadalafil (144 interactions) — ranked by severity →

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 Yellow

ShapeOval

ImprintL;64

Size14 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 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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
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.
UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

13 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 system	Per each	Per 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	$1.27	$38.01 / 30 tablets

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Alyq 20 mg 00480-9277-06	Teva	60 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 27241-0123-02	Ajanta	60 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 31722-0647-30	Camber	30 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 43547-0990-06	Solco	60 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 65862-0880-60	Aurobindo	60 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 69097-0526-03	Cipla	60 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 82009-0080-60	Quallent	60 tablets	$0.140	AB2	Availability likely	—
Tadalafil 20 mg 31722-0646-30	Camber	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 43598-0573-30	Dr.Reddys	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 16714-0077-01	NorthStar	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 27241-0114-03	Ajanta	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 69238-1349-03	Amneal	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 43547-0033-03	Solco	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 60290-0030-01	Umedica	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 72303-0825-01	HEC	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 82009-0079-05	Quallent	500 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 00480-2311-56	Teva	30 tablets	$0.158	AB1	Discontinued	—
Tadalafil 20 mg 75834-0250-01	NIVAGEN	1000 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 43547-0051-03	Solco	30 tablets	$0.158	AB1	Availability likely	—
tadalafil 20 mg 35573-0463-30	Burel	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 16729-0372-10	Accord	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 33342-0268-07	Macleods	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 24979-0730-06	Upsher-Smith	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 62332-0180-30	Alembic	30 tablets	$0.158	AB1	Availability likely	—
Tadalafil 20 mg 47335-0012-83	Sun	30 tablets	$0.192	AB1	FDA listed	—
Cialis 20 mg 00002-4464-30	Eli	30 tablets	$53.837	AB1	Availability likely	—
Tadalafil 20 mg 13668-0581-05	Torrent	500 tablets	—	—	FDA listed	—
Tadalafil 20 mgthis 33342-0278-07	Macleods	30 tablets	—	AB2	FDA listed	—
Tadalafil 20 mg 43598-0578-30	Dr.Reddys	30 tablets	—	AB2	FDA listed	—
Adcirca 20 mg 66302-0467-60	United	60 tablets	—	AB2	FDA listed	—
Tadalafil 20 mg 70518-3931-00	REMEDYREPACK	12 tablets	—	AB2	FDA listed	—
Tadalafil 20 mg 73190-0032-60	AvKARE	60 tablets	—	AB2	FDA listed	—
Tadalafil 20 mg 67184-0526-01	Qilu	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71205-0268-10	Proficient	10 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 71821-0009-01	VKT	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68180-0914-06	Lupin	30 tablets	—	AB2	FDA listed	—
Tadalafil 20 mg 68382-0899-01	Zydus	100 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 70954-0435-10	ANI	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71205-0736-30	Proficient	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71610-0728-04	Aphena	4 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 76420-0544-30	Asclemed	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 76420-0554-05	Asclemed	500 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68788-8445-03	Preferred	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 13668-0568-05	Torrent	500 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68071-3753-03	NuCare	30 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 68788-4083-01	Preferred	15 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71335-1587-01	Bryant	30 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 82804-0112-10	Proficient	10 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 68071-3777-04	NuCare	24 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68071-5186-06	NuCare	60 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71335-1491-01	Bryant	30 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 76420-0857-01	Asclemed	100 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 46708-0180-30	Alembic	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71335-1255-01	Bryant	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 35561-0257-10	Bostal	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 65862-0853-05	Aurobindo	500 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 71335-2583-01	Bryant	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 50090-7152-00	A-S	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 51655-0473-54	Northwind	15 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68788-8664-01	Preferred	15 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 70518-4534-00	REMEDYREPACK	12 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 72789-0396-15	PD-Rx	15 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68071-3781-02	NuCare	12 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 70771-1478-00	Zydus	1000 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71610-0903-04	Aphena	4 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 60219-1349-03	Amneal	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68788-8153-07	Preferred	7 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 71610-0567-04	Aphena	4 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 82804-0042-30	Proficient	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 82868-0028-06	Northwind	6 tablets	—	AB2	FDA listed	—
Tadalafil 20 mg 82968-0005-01	FOURRTS	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 42291-0867-30	AvKARE	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 51655-0063-54	Northwind	15 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68071-2553-03	NuCare	30 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 72789-0344-15	PD-Rx	15 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 80425-0443-01	Advanced	7 tablets	—	AB1	FDA listed	—
tadalafil 20 mg 29300-0289-01	Unichem	100 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 50090-5641-00	A-S	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 72865-0108-30	XLCare	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 72603-0784-01	NorthStar	1000 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68071-2421-01	NuCare	10 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 68071-2632-03	NuCare	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 50090-6150-00	A-S	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 50090-8039-00	A-S	30 tablets	—	AB1	FDA listed	—
Tadalafil 20 mg 50090-8047-00	A-S	30 tablets	—	AB1	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2019

On the market since

Oct 2019

📍

2026

Currently FDA-listed

7 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.

💊 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.

60 tablets33342-0278-09 1,844 Rx · $160,433

30 tablets this page33342-0278-07 No Medicaid data

Drug total (last 4 qtrs): 1,844 Rx · 100,573 units · $160,433 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 Tadalafil — the program that covers self-administered drugs. 21 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 Tadalafil. 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

$15.23M

Claims incl. refills

172.4K

Beneficiaries

114.1K

Spend / beneficiary

$133.51

Spend / claim

$88.34

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 Tadalafil — the ingredient across all brands.

Top reported reactions

Dyspnoea11,917

Headache10,982

Diarrhoea8,020

Nausea6,697

Fatigue6,080

Death5,987

Dizziness5,324

Age at onset

Neonate32

Infant73

Child495

Adolescent453

Adult13,902

Elderly10,988

Reporter sex

Male · 47%

Female · 53%

Unknown · 0%

Serious outcomes

Hospitalization37,213

Death11,084

Life-threatening1,837

Disabling1,335

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Per unit	Per pack	Marketing start	Status
33342-0278-07 You're viewing this	30 TABLET, FILM COATED in 1 BOTTLE (33342-278-07)	—	—	2019-10-30	Active
33342-0278-09	60 TABLET, FILM COATED in 1 BOTTLE (33342-278-09)	$0.1400 / ea	$8.40	2019-10-30	Active

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

This pack shows little to no recent Medicaid volume — the 60 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 33342-0278-07?

NDC 33342-0278-07 is a 30-count package — 30 tablet, film coated in 1 bottle.

What is the difference between NDC 33342-0278-07 and NDC 33342-0278-09?

Both are Tadalafil 20 mg Tablet, Film Coated — the drug itself is identical. NDC 33342-0278-07 is the 30-count package, while NDC 33342-0278-09 is the 60 tablets package.

What NDC number is used to bill for this package of Tadalafil 20 mg Tablet, Film Coated?

Bill NDC 33342-0278-07 — the 11-digit billing format is 33342027807. 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 33342-278-07, 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: 33342-0278-07, written without dashes as 33342027807. 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 33342-0278-07, the first segment (33342) is the labeler code FDA assigned to Macleods Pharmaceuticals Limited; the middle segment (0278) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Macleods Pharmaceuticals 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 tablets (33342-0278-09). 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?

Macleods Pharmaceuticals 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.

📄 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.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 112 words ▾

1 INDICATIONS & USAGE Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%). (1.1)

1.1Pulmonary Arterial Hypertension Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE & ADMINISTRATION 40 mg once daily, with or without food. (2.1) Dividing the dose (40 mg) over the course of the day is not recommended. (2.1) Use with ritonavir requires dosage adjustments. (2.4)

2.1Pulmonary Arterial Hypertension The recommended dose of tadalafil tablet is 40 mg (two 20 mg tablets) taken once daily with or without food. Dividing the dose (40 mg) over the course of the day is not recommended.

2.2Dose Adjustment in Renal Impairment Mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min): Start dosing at 20 mg once daily. Increase to 40 mg once daily based on individual tolerability. Severe (creatinine clearance <30 mL/min and on hemodialysis): Avoid use of tadalafil tablet because of increased tadalafil exposure (AUC), limited clinical experience, and the lack of ability to influence clearance by dialysis [see Use in Specific Populations ( 8.6 )].

2.3Dose Adjustment in Hepatic Impairment Mild or moderate (Child Pugh Class A or B): Because of limited clinical experience in patients with mild to moderate hepatic cirrhosis, consider a starting dose of 20 mg once per day. Severe (Child Pugh Class C): Patients with severe hepatic cirrhosis have not been studied. Avoid use of tadalafil tablet [see Use in Specific Populations ( 8.7 )].

2.4Dose Adjustments for Use with Ritonavir Co-administration of Tadalafil tablet in Patients on Ritonavir In patients receiving ritonavir for at least one week, start tadalafil tablet at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions (7.5 ) and Clinical Pharmacology ( 12.3 )]. Co-administration of Ritonavir in Patients on Tadalafil tablet Avoid use of tadalafil tablet during the initiation of ritonavir.

Stop tadalafil tablet at least 24 hours prior to starting ritonavir. After at least one week following the initiation of ritonavir, resume tadalafil tablet at 20 mg once daily. Increase to 40 mg once daily based upon individual tolerability [see Drug Interactions ( 7.5 ) and Clinical Pharmacology ( 12.3 )].

💊 Dosage Forms and Strengths 32 words ▾

3 DOSAGE FORMS & STRENGTHS 20 mg, yellow, almond shaped, biconvex film coated tablets having 'L 64' debossed on one side and plain on other side. Tablets (not scored): 20 mg (3)

⛔ Contraindications 160 words ▾

4 CONTRAINDICATIONS Concomitant organic nitrates ( 4.1 ) Concomitant Guanylate Cyclase (GC) Stimulators ( 4.2 ) History of known serious hypersensitivity reaction to tadalafil or CIALIS ( 4.3 )

4.1Concomitant Organic Nitrates Tadalafil tablet is contraindicated in patients who are using any form of organic nitrate, either regularly or intermittently. Do not use nitrates within 48 hours of the last dose of tadalafil tablet. Tadalafil tablet potentiates the hypotensive effect of nitrates.

This potentiation is thought to result from the combined effects of nitrates and tadalafil tablet on the nitric oxide/cGMP pathway [see Clinical Pharmacology ( 12.2 )].

4.2Concomitant Guanylate Cyclase (GC) Stimulators Coadministration of GC stimulators such as riociguat with tadalafil tablet is contraindicated. Tadalafil tablet may potentiate the hypotensive effects of GC stimulators.

4.3Hypersensitivity Reactions Tadalafil tablet is contraindicated in patients with a known serious hypersensitivity to tadalafil or CIALIS. Hypersensitivity reactions have been reported; including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypotension: Carefully consider whether patients with certain underlying cardiovascular disease could be adversely affected by vasodilatory effects of tadalafil tablets. Not recommended in patients with pulmonary veno-occlusive disease. ( 5.1 , 5.2 ) Effects on the eye: Sudden loss of vision could be a sign of non-arteritic ischemic optic neuropathy (NAION) and may be permanent.

( 5.3 ) Hearing impairment: Cases of sudden decrease or loss of hearing have been reported with CIALIS. ( 5.4 ) Concomitant PDE5 inhibitors: Avoid use with CIALIS or other PDE5 inhibitors. ( 5.5 ) Prolonged erection: Advise patients to seek emergency treatment if an erection lasts >4 hours.

( 5.6 )

5.1Hypotension Tadalafil tablet has vasodilatory properties that may result in transient decreases in blood pressure. Prior to prescribing tadalafil tablet, carefully consider whether patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with preexisting hypotension, with autonomic dysfunction, with left ventricular outflow obstruction, may be particularly sensitive to the actions of vasodilators.

5.2Worsening Pulmonary Vascular Occlusive Disease Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of tadalafil tablet to patients with veno-occlusive disease, administration of tadalafil tablet to such patients is not recommended. Should signs of pulmonary edema occur when tadalafil tablet is administered, the possibility of associated PVOD should be considered.

5.3Visual Loss When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including tadalafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: low cup to disc ratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia, and smoking.

Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 in males aged ≥50 in the general population. An observational case-crossover study evaluated the risk of NAION when PDE5 inhibitor use, as a class, typical of erectile dysfunction treatment, occurred immediately before NAION onset (within 5 half-lives), compared to PDE5 inhibitor use in a prior time period. The results suggest an approximate 2-fold increase in the risk of NAION, with a risk estimate of 2.15 (95% CI 1.06, 4.34).

A similar study reported a consistent result, with a risk estimate of 2.27 (95% CI 0.99, 5.20). Other risk factors for NAION, such as the presence of “crowded” optic disc, may have contributed to the occurrence of NAION in these studies. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

5.4Hearing Impairment Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in patients taking tadalafil. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions ( 6.2 )].

5.5Combination with Other PDE5 Inhibitors Tadalafil is also marketed for erectile dysfunction. The safety and efficacy of taking tadalafil tablet together with another PDE5 inhibitor has not been studied. Inform patients taking tadalafil tablet not to take other PDE5 inhibitors.

5.6Prolonged Erection There have been reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: · Hypotension [see Warnings and Precautions ( 5.1 )] · Visual Loss [see Warnings and Precautions ( 5.3 ) and Patient Counseling Information ( 17 )] · Hearing loss [see Warnings and Precautions ( 5.4 )] · Priapism [see Warnings and Precautions ( 5.6 )] The most common adverse reaction is headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc. at 1-888-943-3210 or 1-855-926-3384 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to 398 patients with PAH during clinical trials worldwide. In trials of tadalafil, a total of 311 and 251 subjects have been treated for at least 182 days and 360 days, respectively.

The overall rates of discontinuation because of an adverse event (AE) in the placebo-controlled trial were 9% for tadalafil 40 mg and 15% for placebo. The rates of discontinuation because of AEs, other than those related to worsening of PAH, in patients treated with tadalafil 40 mg was 4% compared to 5% in placebo-treated patients. In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity.

Table 1 presents treatment-emergent adverse events reported by ≥9% of patients in the tadalafil 40 mg group and occurring more frequently than with placebo. Table 1: Treatment-Emergent Adverse Events Reported by ≥9% of Patients in tadalafil and More Frequent than Placebo by 2% EVENT Placebo (%) (N=82) Tadalafil 20 mg (%) (N=82) Tadalafil 40 mg (%) (N=79) Headache 15 32 42 Myalgia 4 9 14 Nasopharyngitis 7 2 13 Flushing 2 6 13 Respiratory Tract Infection (Upper and Lower) 6 7 13 Pain in Extremity 2 5 11 Nausea 6 10 11 Back Pain 6 12 10 Dyspepsia 2 13 10 Nasal Congestion (Including sinus congestion) 1 0 9

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of tadalafil. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure.

The list does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section. Cardiovascular and cerebrovascular - Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil [see Contraindications ( 4.1 )]. Most, but not all, of these patients had preexisting cardiovascular risk factors.

Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of tadalafil without sexual activity. Others were reported to have occurred hours to days after the use of tadalafil and sexual activity. It is not possible to determine whether these events are related directly to tadalafil, to sexual activity, to the patient’s underlying cardiovascular disease, to a combination of these factors, or to other factors.

Body as a whole - Hypersensitivity reactions including urticaria, Stevens–Johnson syndrome, and exfoliative dermatitis Nervous - Migraine, seizure and seizure recurrence, and transient global amnesia Ophthalmologic - Visual field defect, retinal vein occlusion, retinal artery occlusion, and NAION [see Warnings and Precautions ( 5.3) and Patient Counseling Information ( 17 )]. Otol…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

7.1Nitrates Administration of nitrates within 48 hours after the last dose of tadalafil is contraindicated [see Contraindications ( 4.1 )] .

7.2Alpha-Blockers PDE5 inhibitors, including tadalafil, and alpha–adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, alfuzosin or tamsulosin [see Clinical Pharmacology ( 12.2 )].

7.3Antihypertensives PDE5 inhibitors, including tadalafil tablet, are mild systemic vasodilators. Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood–pressure–lowering effects of selected antihypertensive medications (amlodipine, angiotensin II receptor blockers, bendroflumethiazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo [see Clinical Pharmacology ( 12.2 )].

7.4Alcohol Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood pressure–lowering effects of each individual compound may be increased. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with tadalafil tablet can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.

Tadalafil (10 mg or 20 mg) did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See Clinical Pharmacology ( 12.2 )].

7.5CYP3A Inhibitors/Inducers Ritonavir Ritonavir initially inhibits and later induces CYP3A, the enzyme involved in the metabolism of tadalafil. At steady state of ritonavir (about 1 week), the exposure to tadalafil is similar as in the absence of ritonavir [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )]. Potent Inhibitors of CYP3A Tadalafil is metabolized predominantly by CYP3A in the liver.

In patients taking potent inhibitors of CYP3A such as ketoconazole, and itraconazole, avoid use of tadalafil tablet [see Clinical Pharmacology ( 12.3)]. Potent Inducers of CYP3A For patients chronically taking potent inducers of CYP3A, such as rifampin, avoid use of tadalafil tablet [see Clinical Pharmacology ( 12.3 )].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Renal Impairment ( 2.2 , 8.6 , 12.3 ) Mild or moderate: Start with 20 mg once daily. ( 2.2 , 8.6 ) Severe: Avoid use of tadalafil. ( 2.2 , 8.6 ) Hepatic Impairment ( 2.2 , 8.7 , 12.3 ) Mild or moderate: Consider starting dose of 20 mg once daily. ( 2.3 , 8.7 ) Severe: Avoid use of tadalafil. ( 2.3 , 8.7 )

8.1Pregnancy Risk Summary Limited data from case series with tadalafil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse developmental effects were observed with oral administration of tadalafil to pregnant rats or mice during organogenesis at exposures 7 times the exposure at the maximum recommended human dose (MRHD) of 40 mg/day based on AUC (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 U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.

Data Animal Data Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given to pregnant rats or mice at unbound tadalafil exposures up to 7 times the exposure at the maximum recommended human dose (MRHD) of 40 mg/day during organogenesis based on AUC. In one of two perinatal/postnatal developmental studies in rats, a reduction of postnatal pup survival was observed at dose levels of 60, 200 and 1000 mg/kg.

The no-observed-effect-level (NOEL) for developmental toxicity was 30 mg/kg, which provided maternal exposure to unbound tadalafil concentrations approximately 5 times the exposure at the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 200 mg/kg/day, which produced AUCs greater than 8 times the exposure at the MRHD. Surviving offspring had normal development and reproductive performance.

8.2Lactation Risk Summary There are no data on the presence of tadalafil and/or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Tadalafil and/or its metabolites are present in the milk of lactating rats at concentrations approximately 2.4-times that found in the plasma. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tadalafil tablet and any potential adverse effects on the breastfed child from tadalafil tablet or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Infertility Males Based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months. This effect was not seen in the study of 20 mg tadalafil taken for 6 months. There was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone.

The clinical significance of the decreased sperm concentrations in the two studies is unknown. There have been no studies evaluating the effect of tadalafil on fertility in men or women [see Clinical Pharmacology ( 12.2 )].

8.4Pediatric Use Safety and effectiveness of tadalafil in pediatric patients have not been established.

8.5Geriatric Use Of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertens…

🤰 Pregnancy ~1 min read ▾

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and effectiveness of tadalafil in pediatric patients have not been established.

🧓 Geriatric Use 83 words ▾

8.5Geriatric Use Of the total number of subjects in the clinical study of tadalafil for pulmonary arterial hypertension, 28 percent were 65 and over, while 8 percent were 75 and over. No overall differences in safety were observed between subjects over 65 years of age compared to younger subjects or those over 75 years of age. No dose adjustment is warranted based on age alone; however, a greater sensitivity to medications in some older individuals should be considered. [See Clinical Pharmacology (12.3)].

🆘 Overdosage 75 words ▾

10 OVERDOSAGE Single doses up to 500 mg have been given to healthy male subjects, and multiple daily doses up to 100 mg have been given to male patients with erectile dysfunction. Adverse reactions were similar to those seen at lower doses. Doses greater than 40 mg have not been studied in patients with pulmonary arterial hypertension.

In cases of overdose, standard supportive measures should be adopted as needed. Hemodialysis contributes negligibly to tadalafil elimination.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tadalafil is an inhibitor of phosphodiesterase type 5 (PDE5), the enzyme responsible for the degradation of cyclic guanosine monophosphate (cGMP). Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations in the pulmonary vascular smooth muscle. PDE5 is the predominant phosphodiesterase in the pulmonary vasculature.

Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed. Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in pulmonary vascular smooth muscle, visceral smooth muscle, corpus cavernosum, skeletal muscle, platelets, kidney, lung, cerebellum, and pancreas.

In vitro studies have shown that the effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. These studies have shown that tadalafil is >10,000–fold more potent for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Tadalafil is >10,000–fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels.

Additionally, tadalafil is 700–fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. Tadalafil is >9,000-fold more potent for PDE5 than for PDE8, PDE9, and PDE10. Tadalafil is 14–fold more potent for PDE5 than for PDE11A1 and 40–fold more potent for PDE5 than for PDE11A4, two of the four known forms of PDE11.

PDE11 is an enzyme found in human prostate, testes, skeletal muscle and in other tissues. In vitro, tadalafil inhibits human recombinant PDE11A1 and, to a lesser degree, PDE11A4 activities at concentrations within the therapeutic range. The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined.

12.2Pharmacodynamics Effects on Blood Pressure When Administered with Nitrates In clinical pharmacology studies, tadalafil (5 to 20 mg) was shown to potentiate the hypotensive effect of nitrates. Do not use tadalafil tablet in patients taking any form of nitrates [see Contraindications ( 4.1 )]. A double–blind, placebo–controlled, crossover study in 150 male subjects at least 40 years of age (including subjects with diabetes mellitus and/or controlled hypertension) assessed the interaction between nitroglycerin and tadalafil.

Subjects received daily doses of tadalafil 20 mg or matching placebo for 7 days and then were given a single dose of 0.4 mg sublingual nitroglycerin (NTG) at pre–specified timepoints following their last dose of tadalafil (2, 4, 8, 24, 48, 72, and 96 hours after tadalafil). A significant interaction between tadalafil and NTG was observed at each timepoint up to and including 24 hours. At 48 hours, by most hemodynamic measures, the interaction between tadalafil and NTG was not observed, although a few more tadalafil subjects compared to placebo experienced greater blood–pressure lowering effects at this timepoint.

After 48 hours, the interaction was not detectable. [See Contraindications ( 4.1 )]. Effects on Blood Pressure. The effects of tadalafil on blood pressure alone and administered with antihypertensives, alcohol, and alpha-blockers is shown in Figure 1. a In some subjects, postural dizziness and orthostatic hypotension were observed.

When tadalafil was administered with lower doses of alcohol (0.6 g/kg), hypotension was not observed, and dizziness occurred at a similar frequency to alcohol alone. b In studies of tadalafil co-administration with doxazosin, the number of subjects with potentially clinically significant standing blood pressure decreases was greater for the combination. Some patients had symptoms associated with the decrease in blood pressure including syncope. Figur…

🧬 Mechanism of Action ~1 min read ▾

📦 How Supplied / Storage and Handling 79 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tadalafil tablets USP is supplied as follows: 20 mg yellow colored, almond shaped, biconvex film coated tablets having ‘L 64’ debossed on one side and plain on other side Bottles of 30 NDC 33342-278-07 Bottles of 60 NDC 33342-278-09

16.2Storage Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children.

📋 Description 145 words ▾

11 DESCRIPTION Tadalafil tablets USP, an oral treatment for pulmonary arterial hypertension, are a selective inhibitor of cyclic guanosine monophosphate (cGMP)–specific phosphodiesterase type 5 (PDE5). Tadalafil USP has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. The structural formula is: The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4–b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-.

It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets USP are available as yellow coloured, almond shaped, biconvex film coated tablets having ‘L64’ debossed on one side and plain on other side for oral administration. Each tablet contains 20 mg of tadalafil USP and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose 6 cPs, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, povidone, sodium citrate dihydrate, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, and triacetin. str

💬 Information for Patients 184 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information) Inform patients of contraindication of tadalafil with any use of organic nitrates or GC stimulators. Inform patients that tadalafil is also marketed as CIALIS for erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking tadalafil not to take CIALIS or other PDE5 inhibitors.

Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking tadalafil. Such an event may be a sign of NAION. Also discuss with patients that there is an increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators such as PDE5 inhibitors.

Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking tadalafil. These events may be accompanied by tinnitus and dizziness. Manufactured by : Macleods Pharmaceuticals Ltd.

Daman (U.T.), India. Manufactured for : Macleods Pharma USA, Inc. Princeton, NJ 08540 Revised : September 2022

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

contraindicated: Should not be used in that situation, because the risk is considered too high.

contraindication: A situation in which a medicine should not be used because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

additive effect: When two medicines that do the same thing are taken together and their effects add up to a larger combined effect.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

dermatitis: Inflammation of the skin, causing redness, itching, and sometimes swelling or blisters.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erectile dysfunction: Trouble getting or keeping an erection.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

exfoliative dermatitis: Widespread redness with heavy scaling or peeling of the skin over most of the body.

fertility: The natural ability to become pregnant or to father a child.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myalgia: Muscle pain or aching.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

nasopharyngitis: Inflammation of the nose and throat, commonly known as the common cold.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

pulmonary edema: A buildup of fluid in the lungs' air sacs that makes it hard to breathe.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

reproductive potential: The ability to have children, meaning a person who could become pregnant or could father a child.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

sublingual: A tablet or spray placed under the tongue, where it dissolves and is absorbed.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vasodilation: Widening of blood vessels, which lets more blood flow through and can lower blood pressure.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

← 33342-0277-07 · Macleods 33342-0279-07 · Macleods →

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.

Tadalafil 20 mg Tablet, Film Coated, 30-count

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