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Tadalafil 20 mg Tablet, Film Coated, 30-count — NDC 75834-0250-10 package photo

Tadalafil 20 mg Tablet, Film Coated, 30-count

by NIVAGEN PHARMACEUTICALS, INC. · 30 TABLET, FILM COATED in 1 BLISTER PACK (75834-250-10)
NDC 75834-0250-10
🏷️ FDA NDC (as labeled) 75834-250-10 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.5398/unit — full pricing hub ↓
Also comes in: 30 tablets 75834-0250-30 1000 tablets 75834-0250-01
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

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) 75834-250-10
Product NDC 75834-250
11-digit billing NDC 75834025010
RxCUI 402019, 403957, 484814, 757707
UNII 742SXX0ICT
UPC 0375834248301, 0375834247304, 0375834250304
Application # ANDA211298
SPL Set ID ca1d46e3-ad9b-48c7-bb7f-63ee678ccf7a
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 2020-11-02
Route ORAL
Dosage form TABLET, FILM COATED
Substance TADALAFIL
GPI-14 40304080000320
GPI class Tadalafil
GCN Seq No 051657
GCN 18996
HICL code 024859
Ingredient (HICL) Tadalafil
HIC1 code F
Therapeutic class — broad (HIC1) Male Genital System
HIC2 code F2
Therapeutic class — intermediate (HIC2) Systemic Fertility Agents
HIC3 code F2A
Therapeutic class — specific (HIC3) Drugs To Treat Erectile Dysfunction (Ed)
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) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 75834-250-10 — 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 → 75834-0250-10. 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

LabelerNIVAGEN PHARMACEUTICALS, INC.
Application holderUMEDICA LABORATORIES PRIVATE LTD
FDA applicationANDA211298 (ANDA)
Labeler code75834
First marketedNov 2020
Product typeHuman Prescription Drug
Portfolio95 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name 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 →
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
ShapeTear
ImprintT20
Size12 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 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 2165RE0K14
    A plant-based thickener made from cellulose that helps control how quickly the medicine dissolves and releases its active ingredient. It also binds ingredients together and improves the tablet's texture and handling during manufacturing.
  • UNII 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • UNII 36SFW2JZ0W
    Hypromellose 2910 is a plant-based thickening agent derived from cellulose. In medicines, it forms a protective coating on tablets or capsules and controls how quickly the drug dissolves and releases into your body.
  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 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.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5398 $16.19 / 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

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

🏛️
2020
On the market since
Nov 2020
📍
2026
Currently FDA-listed
6 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.

📊 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

99,210 reports
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
2019 2021 2023 2026 7,469 0
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 NDCDescription Per unit Per pack Marketing startStatus
75834-0250-01 1000 TABLET, FILM COATED in 1 BOTTLE (75834-250-01) $0.1582 / ea $158.15 2020-11-02 Active
75834-0250-10 You're viewing this 30 TABLET, FILM COATED in 1 BLISTER PACK (75834-250-10) — — 2020-11-02 Active
75834-0250-30 30 TABLET, FILM COATED in 1 BOTTLE (75834-250-30) $0.2714 / ea $8.14 2020-11-02 Active

Pack size FAQ

What quantity is in NDC 75834-0250-10?
NDC 75834-0250-10 is a 30-count package — 30 tablet, film coated in 1 blister pack.
What is the difference between NDC 75834-0250-10 and NDC 75834-0250-30?
Both are Tadalafil 20 mg Tablet, Film Coated — the drug itself is identical. NDC 75834-0250-10 is the 30-count package, while NDC 75834-0250-30 is the 30 tablets package.
What NDC number is used to bill for this package of Tadalafil 20 mg Tablet, Film Coated?
Bill NDC 75834-0250-10 — the 11-digit billing format is 75834025010. 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 75834-250-10, 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: 75834-0250-10, written without dashes as 75834025010. 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 75834-0250-10, the first segment (75834) is the labeler code FDA assigned to NIVAGEN PHARMACEUTICALS, INC.; the middle segment (0250) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 NIVAGEN PHARMACEUTICALS, INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 30 tablets (75834-0250-30), 1000 tablets (75834-0250-01). 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?
NIVAGEN PHARMACEUTICALS, INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
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 189 words ▾

1 INDICATIONS AND USAGE Tadalafil tablet is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: • erectile dysfunction (ED) ( 1.1 ) • the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) • ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ).

1.1Erectile Dysfunction Tadalafil tablets are indicated for the treatment of erectile dysfunction (ED).

1.2Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

1.3Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

1.4Limitation of Use If tadalafil tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of tadalafil tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of tadalafil tablets beyond 26 weeks is unknown [ see Clinical Studies ( 14.3 )].

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Do not split Tadalafil tablets; entire dose should be taken. • Tadalafil tablets for use as needed: • ED: Starting dose: 10 mg as needed prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Improves erectile function compared to placebo up to 36 hours post dose.

Not to be taken more than once per day ( 2.1 ). • Tadalafil tablets for once daily use: • ED: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability ( 2.2 ). • BPH: 5 mg, taken at approximately the same time every day ( 2.3 ) • ED and BPH: 5 mg, taken at approximately the same time every day ( 2.3 , 2.4 ). • Tadalafil tablets may be taken without regard to food ( 2.5 ).

2.1Tadalafil tablets for Use as Needed for Erectile Dysfunction • The recommended starting dose of tadalafil tablets for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity. • The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients. • Tadalafil tablets for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of tadalafil tablets, this should be taken into consideration.

2.2Tadalafil tablets for Once Daily Use for Erectile Dysfunction • The recommended starting dose of tadalafil tablets for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. • The tadalafil tablets dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

2.3Tadalafil tablets for Once Daily Use for Benign Prostatic Hyperplasia • The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day. • When therapy for BPH is initiated with tadalafil tablets and finasteride, the recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

2.4Tadalafil tablets for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

2.5Use with Food Tadalafil tablets may be taken without regard to food.

2.6Use in Specific Populations Renal Impairment Tadalafil tablets for Use as Needed • Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours. • Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 )]. Tadalafil tablets for Once Daily Use Erectile Dysfunction • Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 )].

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia • Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response. • Creatinine clearance less than 30 mL/min or on hemodialysis: Tadalafil tablets for once daily use is not recommended [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.7 )]. Hepatic Impairment Tadalafil tablets for Use as Needed • Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day.

The use of tadalafil tablets once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised. • Severe (Child Pugh Class C): Th…

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS Four strengths of almond-shaped tablets are available in different sizes and yellow color. 2.5 mg tablets debossed with "TAD" 5 mg tablets debossed with "T5" 10 mg tablets debossed with "T10" 20 mg tablets debossed with "T20" Tablets: 2.5 mg, 5 mg, 10 mg, 20 mg ( 3 ).

⛔ Contraindications 176 words ▾

4 CONTRAINDICATIONS • Administration of tadalafil tablets to patients using any form of organic nitrate is contraindicated. Tadalafil tablets were shown to potentiate the hypotensive effect of nitrates ( 4.1 ). • History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA ® ( 4.2 ). • Administration with guanylate cyclase (GC) stimulators, such as, riociguat ( 4.3 ).

4.1Nitrates Administration of tadalafil tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil tablets were shown to potentiate the hypotensive effect of nitrates [ see Clinical Pharmacology ( 12.2 )].

4.2Hypersensitivity Reactions Tadalafil tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (tadalafil tablets or ADCIRCA®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )].

4.3Concomitant Guanylate Cyclase (GC) Stimulators Do not use tadalafil tablets in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including tadalafil tablets may potentiate the hypotensive effects of GC stimulators.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing tadalafil tablets, it is important to note the following: • Patients should not use tadalafil tablets if sex is inadvisable due to cardiovascular status ( 5.1 ). • Use of tadalafil tablets with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ). Tadalafil tablets are not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering.

Caution is advised when tadalafil tablets are used as a treatment for ED in men taking alpha-blockers ( 2.7 , 5.6 , 7.1 , 12.2 ). • Patients should seek emergency treatment if an erection lasts >4 hours. Use tadalafil tablets with caution in patients predisposed to priapism ( 5.3 ). • Patients should stop tadalafil tablets and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION.

Patients with a “crowded” optic disc may also be at an increased risk of NAION ( 5.4 , 6.2 ). • Patients should stop tadalafil tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.5 ). • Prior to initiating treatment with tadalafil tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms ( 5.14 ).

5.1Cardiovascular Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including tadalafil tablets, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets. In such a patient, who has taken tadalafil tablets, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring.

Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention. [see Contraindications ( 4.1 ) and Patient Counseling Information ( 17.1 )]. Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors. The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for tadalafil tablets, and therefore until further information is available, tadalafil tablets are not recommended for the following groups of patients: • myocardial infarction within the last 90 days • unstable angina or angina occurring during sexual intercourse • New York Heart Association Class 2 or greater heart failure in the last 6 months • uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension • stroke within the last 6 months.

As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressu…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-332-1088 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 over 9000 men during clinical trials worldwide. In trials of tadalafil tablets for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively.

For tadalafil tablets for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. Tadalafil tablets for Use as Needed for ED In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients. When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported ( see Table 1) for tadalafil tablets for use as needed: Table 1: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with tadalafil tablets (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo-Controlled Clinical Studies (Including a Study in Patients with Diabetes) for tadalafil tablets for Use as Needed for ED Adverse Reaction Placebo (N=476) Tadalafil 5 mg (N=151) Tadalafil 10 mg (N=394) Tadalafil 20 mg (N=635) Headache 5% 11% 11% 15% Dyspepsia 1% 4% 8% 10% Back pain 3% 3% 5% 6% Myalgia 1% 1% 4% 3% Nasal congestion 1% 2% 3% 3% Flushing a 1% 2% 3% 3% Pain in limb 1% 1% 3% 3% a The term flushing includes: facial flushing and flushing Tadalafil tablets for Once Daily Use for ED In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo- treated patients.

The following adverse reactions were reported ( see Table 2) in clinical trials of 12 weeks duration: Table 2: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil tablets for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes) for Tadalafil tablets for Once Daily Use for ED Adverse Reaction Placebo (N=248) Tadalafil 2.5 mg (N=196) Tadalafil 5 mg (N=304) Headache 5% 3% 6% Dyspepsia 2% 4% 5% Nasopharyngitis 4% 4% 3% Back pain 1% 3% 3% Upper respiratory tract infection 1% 3% 3% Flushing 1% 1% 3% Myalgia 1% 2% 2% Cough 0% 4% 2% Diarrhea 0% 1% 2% Nasal congestion 0% 2% 2% Pain in extremity 0% 1% 2% Urinary tract infection 0% 2% 0% Gastroesophageal reflux disease 0% 2% 1% Abdominal pain 0% 2% 1% The following adverse reactions were reported ( see Table 3) over 24 weeks treatment duration in one placebo- controlled clinical study: Table 3: Treatment-Emergent Adverse Reactions Reported by ≥2% of Patients Treated with Tadalafil tablets for Once Daily Use (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 WeeksTreatment Duration for tadalafil tablets for Once Daily Use for ED Adverse Reaction Placebo (N=94) Tadalafil 2.5 mg (N=96) Tadalafil 5 mg (N=97) Nasopharyngitis 5% 6% 6% Gastroenteritis 2% 3% 5% Back pain 3% 5% 2% Upper respiratory tract infection 0% 3% 4% Dyspepsia 1% 4% 1% Gastroesophageal reflux disease 0% 3% 2% Myalgia 2% 4% 1% Hypertension 0% 1% 3% Nasal congestion 0% 0% 4% Tadalafil tablets for Once Daily Use for B…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Tadalafil tablets can potentiate the hypotensive effects of nitrates, alpha-blockers, antihypertensives or alcohol ( 7.1 ). • CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) increase tadalafil tablets exposure ( 2.7 , 5.10 , 7.2 ) requiring dose adjustment: • Tadalafil tablets for use as needed: no more than 10 mg every 72 hours • Tadalafil tablets for once daily use: dose not to exceed 2.5 mg • CYP3A4 inducers (e.g. rifampin) decrease tadalafil tablets exposure ( 7.2 )

7.1Potential for Pharmacodynamic Interactions with Tadalafil Tablets Nitrates — Administration of tadalafil tablets to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, tadalafil tablets were shown to potentiate the hypotensive effect of nitrates. In a patient who has taken tadalafil tablets, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of tadalafil tablets before nitrate administration is considered.

In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Dosage and Administration ( 2.7 ), Contraindications ( 4.1 ), and Clinical Pharmacology ( 12.2 )]. Alpha-Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including tadalafil tablets, 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, tamsulosin or alfuzosin. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.6 ), and Clinical Pharmacology ( 12.2 )]. Antihypertensives — PDE5 inhibitors, including tadalafil, 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, bendrofluazide, enalapril, and metoprolol). Small reductions in blood pressure occurred following coadministration of tadalafil tablets with these agents compared with placebo. [see Warnings and Precautions ( 5.6 ) and Clinical Pharmacology ( 12.2 )]. Alcohol — 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 tablets can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [see Warnings and Precautions ( 5.9 ) and Clinical Pharmacology ( 12.2 )].

7.2Potential for Other Drugs to Affect Tadalafil Tablets [See Dosage and Administration (2.7) and Warnings and Precautions ( 5.10 )]. Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil. H 2 Antagonists (e.g.

Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics. Cytochrome P450 Inhibitors — Tadalafil tablets are a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.

CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and C max by 22%, relative to the values for ta…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment ( 2.6 , 5.8 , 8.6 ): • Mild or Moderate: Dosage adjustment may be needed. • Severe: Use is not recommended. Renal Impairment ( 2.6 , 5.7 , 8.7 ): • Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. • Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Once daily use is not recommended.

8.1Pregnancy Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental 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 up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day ( see Data).

Data Animal Data Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given orally to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In a pernatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC.

Surviving offspring had normal development and reproductive performance. In another rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. The no observed effect level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day.

This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg. Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.

8.2Lactation Risk Summary Tadalafil tablets are not indicated for use in females. There is no information on the presence of tadalafil and/or 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-fold greater than found in the plasma.

8.3Females and Males of Reproductive Potential Infertility 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 [see Clinical Pharmacology ( 12.2 )]. Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology ( 13.1 )].

8.4Pediatric Use Tadalafil tablets are not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received tadalafil tablets 0.3 mg/kg, tadalafil tablets 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with tadalafil tablets on a range of assessments of muscle strength and performance.

Juvenile Animal Study No adverse effects were observed in a study in which tadalafil was administered orally at doses of 60, 200, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90. The highest plasma tad…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Tadalafil tablets are not indicated for use in females. There are no data with the use of tadalafil tablets in pregnant women to inform any drug-associated risks for adverse developmental 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 up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day ( see Data).

Data Animal Data Animal reproduction studies showed no evidence of teratogenicity, embryotoxicity, or fetotoxicity when tadalafil was given orally to pregnant rats or mice at exposures up to 11 times the maximum recommended human dose (MRHD) of 20 mg/day during organogenesis. In a pernatal/postnatal developmental studies in rats, postnatal pup survival decreased following maternal exposure to tadalafil doses greater than 10 times the MRHD based on AUC. Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC.

Surviving offspring had normal development and reproductive performance. In another rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. The no observed effect level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day.

This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg. Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.

🧒 Pediatric Use 131 words ▾

8.4Pediatric Use Tadalafil tablets are not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years have not been established. A randomized, double-blind, placebo-controlled trial in pediatric patients (7 to 14 years of age) with Duchenne muscular dystrophy, who received tadalafil tablets 0.3 mg/kg, tadalafil tablets 0.6 mg/kg, or placebo daily for 48 weeks failed to demonstrate any benefit of treatment with tadalafil tablets on a range of assessments of muscle strength and performance.

Juvenile Animal Study No adverse effects were observed in a study in which tadalafil was administered orally at doses of 60, 200, and 1000 mg/kg/day to juvenile rats on postnatal days 14 to 90. The highest plasma tadalafil exposures (AUC) achieved were approximately 10-fold that observed at the MRHD.

🧓 Geriatric Use 158 words ▾

8.5Geriatric Use Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. Of the total number of subjects in BPH clinical studies of tadalafil (including the ED/BPH study), approximately 40 percent were over 65, while approximately 10 percent were 75 and over. In these clinical trials, no overall differences in efficacy or safety were observed between older (>65 and ≥75 years of age) and younger subjects (≤65 years of age).

However, in placebo-controlled studies with tadalafil tablets for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with tadalafil tablets (2.5% of patients) [see Adverse Reactions ( 6.1 )] . 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 55 words ▾

10 OVERDOSAGE Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum.

The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established. Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5.

PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, 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 (e.g., adrenal cortex). 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 Tadalafil 20 mg administered to healthy male subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (difference in the mean maximal decrease of 1.6/0.8 mm Hg, respectively) and in standing systolic and diastolic blood pressure (difference in the mean maximal decrease of 0.2/4.6 mm Hg, respectively). In addition, there was no significant effect on heart rate. 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.

Therefore, the use of tadalafil tablets in patients taking any form of nitrates is contraindicated [see Contraindications ( 4.1 )]. A study was conducted to assess the degree of interaction between nitroglycerin and tadalafil, should nitroglycerin be required in an emergency situation after tadalafil was taken. This was 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) and receiving daily doses of tadalafil 20 mg or matching placebo for 7 days.

Subjects were administered 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). The objective…

🧬 Mechanism of Action ~2 min read ▾

12.1Mechanism of Action Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum.

The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established. Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5.

PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, 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 (e.g., adrenal cortex). 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.

📦 How Supplied / Storage and Handling 173 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Tadalafil tablets USP are supplied as follows: Four strengths of almond-shaped tablets are available in yellow color and different sizes, and supplied in the following package sizes: 2.5 mg tablets debossed with “TAD” Bottle of 30 with child-resistant closure, NDC 75834-247-30 Bottle of 1000 NDC 75834-247-01 Blisters of 2 x 15 NDC 75834-247-15 5 mg tablets debossed with “T5” Bottle of 30 with child-resistant closure, NDC 75834-248-30 Bottle of 1000 NDC 75834-248-01 Blisters of 2 x 15 NDC 75834-248-15 10 mg tablets debossed with “T10” Bottle of 30 with child-resistant closure, NDC 75834-249-30 Bottle of 1000 NDC 75834-249-01 Blisters of 3 x 10 NDC 75834-249-10 20 mg tablets debossed with “T20” Bottle of 30 with child-resistant closure, NDC 75834-250-30 Bottle of 1000 NDC 75834-250-01 Blisters of 3 x 10 � NDC 75834-250-10

16.2Storage Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Bottle of 30s package is child resistant. Keep out of reach of children.

📋 Description 118 words ▾

11 DESCRIPTION Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil 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 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 white or almost white powder, freely soluble in dimethylsulphoxide, slightly soluble in methylene chloride and practically insoluble in water.

Tadalafil tablets, USP are available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: low substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, yellow iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin. tadalafil-structure

💬 Information for Patients ~3 min read ▾

17 PAITENT COUNSELLING INFORMATION “See FDA-approved patient labeling (Patient Information)”

17.1Nitrates Physicians should discuss with patients the contraindication of tadalafil tablets with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of tadalafil tablets with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of tadalafil tablets.

In such a patient, who has taken tadalafil tablets, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil tablets before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking tadalafil tablets should seek immediate medical attention [see Contraindications ( 4.1 ) and Warnings and Precautions ( 5.1 )].

17.2Guanylate Cyclase (GC) Stimulators Physicians should discuss with patients the contraindication of tadalafil tablets with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of tadalafil tablets with GC stimulators may cause blood pressure to drop to an unsafe level.

17.3Cardiovascular Considerations Physicians should consider the potential cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Physicians should advise patients who experience symptoms upon initiation of sexual activity to refrain from further sexual activity and seek immediate medical attention [see Warnings and Precautions ( 5.1 )].

17.4Concomitant Use with Drugs Which Lower Blood Pressure Physicians should discuss with patients the potential for tadalafil tablets to augment the blood-pressure-lowering effect of alpha-blockers, and antihypertensive medications [see Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.1 ), and Clinical Pharmacology ( 12.2 )].

17.5Potential for Drug Interactions When Taking tadalafil tablets for Once Daily Use Physicians should discuss with patients the clinical implications of continuous exposure to tadalafil when prescribing tadalafil tablets for once daily use, especially the potential for interactions with medications (e.g., nitrates, alphablockers, antihypertensives and potent inhibitors of cytochrome P450 3A4) and with substantial consumption of alcohol. [see Dosage and Administration ( 2.7 ), Warnings and Precautions ( 5.6 ), Drug Interactions ( 7.1 , 7.2 ), Clinical Pharmacology ( 12.2 ), and Clinical Studies ( 14.2 )].

17.6Priapism There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

17.7Sudden Loss of Vision Physicians should advise patients to stop use of all PDE5 inhibitors, including tadalafil tablets, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including possible permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. Physicians should discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye.

Physicians should also discuss with patients…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.