Medical emergency?Emergency? Call 911. Nearest emergency roomsNearest ERs

Español Near me My list Help
US Patient GuideUSA
Surprise me
Prescription medicine · generic available

Tadalafil

Brand names: Cialis, Tadliq, Adcirca, Alyq

Drug class: Phosphodiesterase 5 Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

Some labelsBoxed warning
None listedFDA shortage list
9Recalls (FDA reports)
50Companies
2003First FDA approval on file

Quick answers

What is Tadalafil used for?
The FDA-approved label (Cialis, Eli Lilly and Company, June 3, 2026) says: “CIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH) ED and the signs and symptoms of BPH (ED/BPH) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks. 1.1 Erectile Dysfunction CIALIS ® is indicated for the treatment of erectile dysfunction (ED). …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Tadalafil have a boxed warning?
The label we quote has no boxed warning, but 1 of 136 FDA labels for this medicine do. Check the label of your own product.
Is there a shortage of Tadalafil?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Tadalafil been recalled?
FDA enforcement reports list 9 recalls of products of this medicine; the newest started March 23, 2023 (Class II). A recall usually concerns specific lots, not every product.
Who makes Tadalafil?
50 companies list prescription products of Tadalafil in the FDA NDC Directory, including NuCare Pharmaceuticals, Inc., Bryant Ranch Prepack and Asclemed USA, Inc..

What Tadalafil is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

CIALIS ® is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH) ED and the signs and symptoms of BPH (ED/BPH) If CIALIS is used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks. 1.1 Erectile Dysfunction CIALIS ® is indicated for the treatment of erectile dysfunction (ED). …

— FDA label: Cialis, Eli Lilly and Company, effective June 3, 2026. Read the full label on DailyMed →

The FDA has 136 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Erectile dysfunction

Related medical specialties

Urology

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

1 of 136 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet, film coated · Tablet · Tablet, coated · Suspension
RouteOral
Prescription products251 in the FDA NDC Directory
Brand namesCialis, Tadliq, Adcirca, Alyq

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Tadalafil, by strength and form
Strength and formGeneric or brandPharmacies pay
tadalafil 10 mg
tablet		 Generic $0.1533 per tablet
tadalafil 10 mg
tablet, coated		 Generic $0.1533 per tablet
tadalafil 10 mg
tablet, film coated		 Generic $0.1533 per tablet
tadalafil 10 mg
tablet, film coated		 Brand: Cialis $53.69 per tablet
tadalafil 2.5 mg
tablet		 Generic $0.1203 per tablet
tadalafil 2.5 mg
tablet, coated		 Generic $0.1203 per tablet
tadalafil 2.5 mg
tablet, film coated		 Generic $0.1203 per tablet
tadalafil 20 mg
tablet		 Generic $0.1448–$0.1887 per tablet
14 packages, lowest to highest
tadalafil 20 mg
tablet, coated		 Generic $0.1887 per tablet
tadalafil 20 mg
tablet, film coated		 Generic $0.1448–$0.1887 per tablet
24 packages, lowest to highest
tadalafil 20 mg
tablet, film coated		 Brand: Cialis $53.76 per tablet
tadalafil 20 mg/5 mL
suspension		 Brand: Tadliq $13.59 per mL
tadalafil 5 mg
tablet		 Generic $0.1078 per tablet
tadalafil 5 mg
tablet, coated		 Generic $0.1078 per tablet
tadalafil 5 mg
tablet, film coated		 Generic $0.1078 per tablet
tadalafil 5 mg
tablet, film coated		 Brand: Cialis $9.21 per tablet

NADAC list of November 4, 2026; these prices took effect between March 18, 2026 and October 28, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA021368
CIALIS		 LillyNovember 21, 2003 21, latest February 15, 2018
2018: Efficacy · 2017: Labeling · 2016: Manufacturing (CMC)
NDA022332
ADCIRCA		 Eli Lilly CoMay 22, 2009 6, latest September 15, 2020
2020: Labeling · 2017: Labeling · 2015: Labeling
NDA214522
TADLIQ		 Cmp Dev LLCJune 17, 2022 —

Generic approvals (31)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. March 23, 2023 · Class II · Ongoing · D-0526-2023

    cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

    Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7 — Preferred Pharmaceuticals, Inc.

  2. March 16, 2023 · Class II · Ongoing · D-0554-2023

    CGMP Deviations

    Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52 — Northwind Pharmaceuticals LLC

  3. March 16, 2023 · Class II · Ongoing · D-0553-2023

    CGMP Deviations

    Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. — Northwind Pharmaceuticals LLC

  4. February 7, 2023 · Class II · Terminated · D-0416-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, N — Accord Healthcare, Inc.

  5. February 7, 2023 · Class II · Terminated · D-0414-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, — Accord Healthcare, Inc.

  6. February 7, 2023 · Class II · Terminated · D-0417-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, — Accord Healthcare, Inc.

  7. February 7, 2023 · Class II · Terminated · D-0415-2023

    CGMP Deviations: recalling drug products following an FDA inspection.

    Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, N — Accord Healthcare, Inc.

  8. October 25, 2021 · Class II · Terminated · D-0231-2022

    Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

    Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-077-01 — SUN PHARMACEUTICAL INDUSTRIES INC

  9. October 25, 2021 · Class II · Terminated · D-0230-2022

    Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the product.

    Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited, India, NDC # 16714-075-01 — SUN PHARMACEUTICAL INDUSTRIES INC

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)402019, 402096, 402097, 403957, 404711, 484814, 757707, 849866, 2110455, 2123194 … (+2)
SPL set ID of the quoted labelbcd8f8ab-81a2-4891-83db-24a0b0e25895
FDA labels (SPL)136
FDA applicationsNDA021368, NDA022332, NDA214522, 31 ANDA
Active ingredients (FDA)TADALAFIL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cialis, Eli Lilly and Company, effective June 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

Report an error → · Information for medicine makers