TADLIQ: Tadalafil Oral Suspension Overview

TADLIQ Product Facts at a Glance

TADLIQ is a single-ingredient tadalafil prescription product approved under NDA 214522. FDA approved the new drug application in June 2022, and the currently listed DailyMed product is marketed as an oral suspension by CMP Pharma, Inc.

Unlike tablet products, TADLIQ expresses strength as an amount of tadalafil per liquid volume. The labeled concentration is 20 mg per 5 mL, which is equivalent to 4 mg of tadalafil in each milliliter.

TADLIQ Is a Branded Tadalafil Liquid Product

Tadalafil is the active pharmaceutical ingredient, while TADLIQ identifies a specific finished oral-suspension product. The distinction matters because tadalafil is also marketed in tablet products with different brand names, indications and product instructions.

TADLIQ's defining product feature is its liquid dosage form combined with a PAH label context. Its concentration, bottle size, measured-volume instructions and suspension-handling requirements are therefore part of the branded product identity rather than incidental packaging details.

The wider naming landscape is covered on tadalafil brand names, while the general characteristics of liquid tadalafil belong on the tadalafil oral-suspension page.

What Is TADLIQ Approved to Treat?

Current U.S. labeling indicates TADLIQ for pulmonary arterial hypertension, classified as WHO Group 1, to improve exercise ability. The label describes effectiveness data largely from patients with NYHA Functional Class II to III symptoms and PAH of idiopathic, heritable or connective-tissue-disease-associated etiologies.

That indication should not be expanded into a claim that TADLIQ is labeled for every form of pulmonary hypertension. Pulmonary hypertension is a broader disease category, while the current TADLIQ indication specifically names WHO Group 1 PAH.

The clinical disease framework is covered separately on tadalafil for pulmonary hypertension so that this page remains centered on the branded suspension.

How 20 mg/5 mL Relates to the TADLIQ Dose

TADLIQ contains 20 mg of tadalafil in every 5 mL of suspension. Expressed another way, each milliliter contains 4 mg of tadalafil, so the standard 40 mg labeled PAH dose corresponds to a measured volume of 10 mL.

Current labeling recommends 40 mg, or 10 mL, once daily with or without food. The concentration should not be confused with the total daily dose: 20 mg/5 mL describes product strength, whereas 40 mg/10 mL describes the standard labeled amount taken in one day.

This concentration-to-volume relationship is a core TADLIQ product fact. Broader questions about liquid dosing, measuring devices or formulation principles belong on the tadalafil oral-suspension page.

What the TADLIQ Suspension Looks Like

The current prescribing information describes TADLIQ as a white to off-white, opaque oral suspension with a peppermint flavor. These characteristics help identify the branded finished product but should not be generalized to every compounded or commercially available liquid containing tadalafil.

The suspension is supplied ready for oral use in a 150 mL bottle. Because suspended drug particles need to be redistributed uniformly through the liquid before a dose is measured, current product labeling specifically instructs users to shake the bottle well for 30 seconds before use.

These are product-specific handling facts. The broader pharmaceutical reasons suspensions require mixing, and the differences between commercial and compounded liquid formulations, are outside this page's scope.

Current TADLIQ Packaging and Product Identification

DailyMed currently lists TADLIQ 20 mg/5 mL in a 150 mL bottle under NDC 46287-045-15. The principal display panel identifies the product as tadalafil oral suspension and prominently states both the concentration and the instruction to shake well for 30 seconds before use.

The marketed product is associated with NDA 214522 and CMP Pharma, Inc. Product identification should therefore rely on the prescription label, concentration, NDC and official packaging rather than simply assuming that any tadalafil liquid is TADLIQ.

Current DailyMed marketing information shows an active marketing status for this NDC, with a listed marketing start date of August 30, 2022.

TADLIQ Was Approved as a New Tadalafil Dosage Form

FDA approved NDA 214522 for TADLIQ in June 2022. The application was submitted under section 505(b)(2) and covered tadalafil oral suspension at 4 mg/mL for the PAH indication.

The approval is important product context because tadalafil itself had already been approved in the United States years earlier. TADLIQ therefore represents a later finished-product and dosage-form approval rather than the first U.S. approval of the tadalafil molecule.

This distinction prevents the label phrase "Initial U.S. Approval: 2003" from being mistaken for the approval date of the TADLIQ brand itself.

TADLIQ Is Not Simply a Tadalafil Tablet in Liquid Form

TADLIQ shares tadalafil as its active ingredient with tablet products, but a finished drug product is defined by more than the active molecule. Dosage form, concentration, excipients, packaging, administration instructions and indication-specific labeling all form part of the approved product context.

For PAH, Adcirca is a branded tadalafil tablet product, whereas TADLIQ is an oral suspension. Their shared active ingredient and PAH context do not make their physical dosage forms identical or allow suspension volumes and tablet counts to be treated as the same unit.

This page intentionally avoids a full tablet-versus-suspension comparison because that belongs on the tadalafil oral-suspension page. Product-specific information about the tablet brand is available on the Adcirca page.

How Tadalafil Works in the TADLIQ PAH Context

Tadalafil inhibits phosphodiesterase type 5, reducing degradation of cyclic GMP. In pulmonary vascular smooth muscle, increased cGMP signaling supports relaxation and vasodilation of the pulmonary vascular bed.

The molecular mechanism is a property of tadalafil rather than something unique to the liquid formulation. What makes TADLIQ distinct is the finished suspension product and its labeled PAH use, not a different pharmacologic target.

This distinction helps keep product formulation and drug mechanism separate when comparing tadalafil products.

TADLIQ Can Be Taken With or Without Food

Current labeling states that TADLIQ 40 mg, or 10 mL, is taken once daily with or without food. Food therefore does not create a fasting requirement for the standard labeled PAH regimen.

The more product-specific administration instruction is the requirement to shake the suspension well for 30 seconds before use. Meal timing and suspension preparation are separate issues and should not be conflated.

Major TADLIQ Contraindications and Safety Boundaries

Current labeling contraindicates TADLIQ with organic nitrates because tadalafil can potentiate nitrate-related hypotension. Guanylate cyclase stimulators such as riociguat are also contraindicated, as is use in patients with a known serious hypersensitivity reaction to tadalafil products.

The label additionally addresses systemic hypotension, pulmonary veno-occlusive disease, sudden vision loss, sudden hearing decrease or loss, prolonged erection or priapism and combination with other PDE5 inhibitors. These are tadalafil safety issues expressed within the TADLIQ product context.

Detailed safety interpretation belongs on tadalafil contraindications and tadalafil drug interactions.

Adverse-Reaction Context in the TADLIQ Label

The TADLIQ prescribing-information highlights identify headache as the most common adverse reaction. The broader PAH clinical-trial dataset for tadalafil also includes events such as myalgia, flushing, respiratory tract infection, pain in an extremity, nausea, back pain and dyspepsia.

Those trial frequencies reflect tadalafil studied in a PAH population and should not be treated as universal adverse-event percentages across every tadalafil indication or product. The purpose of this section is to establish the TADLIQ safety context rather than reproduce a full adverse-event review.

TADLIQ Has Important Drug-Interaction Context

Tadalafil is predominantly metabolized through CYP3A, so strong inhibitors or inducers can change exposure. Current TADLIQ labeling includes specific instructions for ritonavir and advises avoiding use with potent CYP3A inhibitors such as ketoconazole or itraconazole and with chronic potent CYP3A inducers such as rifampin.

The label also addresses alpha-blockers, antihypertensive agents and substantial alcohol intake because tadalafil is a systemic vasodilator and additive blood-pressure effects may occur. These interaction principles are part of the active drug's pharmacology rather than a property unique to the suspension.

Medication-specific depth belongs on tadalafil drug interactions, with CYP metabolism covered on tadalafil and CYP3A4.

Kidney and Liver Function Can Change the TADLIQ Framework

Current labeling modifies the TADLIQ framework in renal impairment. For mild or moderate renal impairment, treatment starts at 20 mg, or 5 mL, once daily and may be increased to 40 mg, or 10 mL, according to individual tolerability.

TADLIQ should be avoided in severe renal impairment because tadalafil exposure is increased, clinical experience is limited and dialysis does not meaningfully provide a way to influence clearance. For mild or moderate hepatic cirrhosis, the label says to consider a 20 mg, or 5 mL, once-daily starting dose; severe hepatic cirrhosis is an avoid-use setting.

The underlying exposure evidence belongs on tadalafil and renal impairment and tadalafil and hepatic impairment.

TADLIQ Storage and Handling

Current labeling instructs that TADLIQ be stored at controlled room temperature, 20°C to 25°C (68°F to 77°F), with permitted excursions from 15°C to 30°C (59°F to 86°F). The product should be dispensed in a tight container and kept out of reach of children.

The defining handling instruction is to shake the bottle well for 30 seconds before use. That instruction appears both in the prescribing information and prominently on the package label, making it part of routine product handling rather than an optional preparation step.

Common Misunderstandings About TADLIQ

TADLIQ is sometimes described simply as liquid tadalafil, but that shorthand omits important product details. TADLIQ is a specific FDA-approved oral suspension with a defined concentration, PAH indication, bottle presentation and administration instructions.

The concentration 20 mg/5 mL also should not be mistaken for the standard total daily PAH dose. The standard labeled framework is 40 mg once daily, corresponding to 10 mL of the suspension.

Finally, TADLIQ is not an ED-branded liquid counterpart to Cialis. Its U.S. label is centered on PAH, and sharing tadalafil with other products does not make their indications or finished dosage forms interchangeable.

Key Takeaways: TADLIQ

TADLIQ is an FDA-approved branded tadalafil oral suspension indicated for pulmonary arterial hypertension, WHO Group 1, to improve exercise ability. It is supplied at 20 mg/5 mL, equivalent to 4 mg/mL, in a 150 mL bottle.

The standard labeled PAH framework is 40 mg, or 10 mL, once daily with or without food. Current product instructions require the suspension to be shaken well for 30 seconds before use, and the bottle is identified by NDC 46287-045-15.

TADLIQ shares tadalafil's PDE5 pharmacology with tablet products but remains a distinct finished dosage form with its own concentration, packaging and administration instructions. General liquid-formulation mechanics should therefore be separated from the specific facts that define the branded TADLIQ product.