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Alfuzosin Hydrochloride 10 mg Tablet, Film Coated, Extended Release, 90-count — NDC 57237-0114-90 package photo

Alfuzosin Hydrochloride 10 mg Tablet, Film Coated, Extended Release, 90-count

by Rising Pharma Holdings, Inc. · 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-90)
NDC 57237-0114-90
🏷️ FDA NDC (as labeled) 57237-114-90 billing pads the product segment with a zero
This package
Contains90-count Cost per ea$0.1077 NADAC Per package$9.69 / 90 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.2900/unit · Part D plans $0.3752/unit — full pricing hub ↓
Also comes in: 100 tablets 57237-0114-01 500 tablets 57237-0114-05
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

🆔 Identity & classification

FDA NDC (as labeled) 57237-114-90
Product NDC 57237-114
11-digit billing NDC 57237011490
NCPDP billing unit EA — each (per item)
RxCUI 861132
UNII 75046A1XTN
Application # ANDA079060
SPL Set ID 43675e9d-a361-4109-9ae1-54d80580fbbd
Established class (EPC) alpha-Adrenergic Blocker
Mechanism of action Adrenergic alpha-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-08-30
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance ALFUZOSIN HYDROCHLORIDE
GPI-14 56852010107530
GPI class Alfuzosin HCl ER
GCN Seq No 045052
GCN 92024
HICL code 010802
Ingredient (HICL) Alfuzosin Hcl
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q9
Therapeutic class — intermediate (HIC2) Urological Preparations
HIC3 code Q9B
Therapeutic class — specific (HIC3) Benign Prostatic Hypertrophy/Micturition Agents
AHFS code 12:16.04.12
AHFS class Selective Alpha-1-Adrenergic Block.agent
FDB label name ALFUZOSIN HCL ER 10 MG TABLET
FDB brand name Alfuzosin Hcl Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 57237-114-90 — 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 → 57237-0114-90. 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 alpha-Adrenergic Blocker class.

Pharmacologic class alpha-Adrenergic Blocker
Drug family (ATC) Alpha-adrenoreceptor antagonists
How it works Adrenergic alpha-Antagonists
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

LabelerRising Pharma Holdings, Inc.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA079060 (ANDA)
Labeler code57237
First marketedAug 2012
Product typeHuman Prescription Drug
Portfolio525 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 ALFUZOSIN HCL ER 10 MG TABLET Ingredient Alfuzosin Hcl
📗 Our plain-language guide HelloPharmacist
  • It's designed to relax the muscles around your prostate and the outlet of your bladder. When those muscles loosen up, urine can flow more easily. Most men notice improvements in sy...
  • What exactly is alfuzosin supposed to do for me?
  • Yes, this one really does matter. Taking alfuzosin without food reduces the amount your body absorbs by about half, which means it won't work as well. Try to take it with the same...
  • Does it matter if I take it with food? What if I forget to eat?
📖 Read our full Alfuzosin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 White
ShapeRound
ImprintX;23
Size8 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 L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII Z135WT9208
    Carbomer is a synthetic polymer that forms a thick, gel-like consistency. It's used in medicines as a thickener and stabilizer to improve texture and keep ingredients evenly mixed throughout the product.
  • UNII Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • UNII B1QE5P712K
    Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
  • UNII R75537T0T4
    Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
  • 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 U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 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 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.

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

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

Inactive ingredient FAQ

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

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.108 $9.69 / 90 tablets
Medicaid paysCMS SDUD · 12 mo $0.2900 $26.10 / 90 tablets
Medicare drug plans payPart D · Q2 2026 $0.3752 $33.77 / 90 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.134 $0.107
▼ Down 5% over the last 24 months.
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
Alfuzosin hydrochloride 10 mg 29300-0155-01 Unichem 100 tablets $0.108 AB Availability likely —
Alfuzosin Hydrochloride 10 mgthis 57237-0114-90 Rising 90 tablets $0.108 AB Availability likely —
Alfuzosin Hydrochloride 10 mg 60505-2850-09 Apotex 90 tablets $0.108 AB Availability likely —
Alfuzosin hydrochloride 10 mg 76282-0302-01 Exelan 100 tablets $0.108 AB Availability likely —
Alfuzosin hydrochloride 10 mg 43353-0945-16 Aphena 6000 tablets — AB FDA listed —
Alfuzosin Hydrochloride 10 mg 47335-0956-08 Sun 100 tablets — — FDA listed —
Alfuzosin Hydrochloride 10 mg 51655-0087-52 Northwind 30 tablets — AB FDA listed —
Alfuzosin Hydrochloride 10 mg 51655-0432-52 Northwind 30 tablets — — FDA listed —
Alfuzosin hydrochloride 10 mg 51655-0967-52 Northwind 30 tablets — AB FDA listed —
Uroxatral 10 mg 59212-0200-10 Advanz 100 tablets — AB FDA listed —
Alfuzosin hydrochloride 10 mg 63629-9155-01 Bryant 30 tablets — AB FDA listed —
Alfuzosin Hydrochloride 10 mg 65862-0249-01 Aurobindo 100 tablets — AB FDA listed —
Alfuzosin Hydrochloride extended release 10 mg 69097-0844-02 Cipla 30 tablets — AB FDA listed —
Alfuzosin Hydrochloride 10 mg 71335-2146-01 Bryant 30 tablets — — FDA listed —
Alfuzosin Hydrochloride 10 mg 71335-2578-01 Bryant 30 tablets — AB FDA listed —
Alfuzosin Hydrochloride 10 mg 72162-1449-09 Bryant 90 tablets — — FDA listed —
Alfuzosin Hydrochloride 10 mg 84386-0153-01 Aurobindo 100 tablets — AB 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

🏛️
2012
On the market since
Aug 2012
📍
2026
Currently FDA-listed
14 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 & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 57237-0114-90, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
55K
Units reimbursed last 4 qtrs
2.6M
Gross reimbursed last 4 qtrs
$746.5K
Avg / prescription
$13.57
Avg / unit
$0.2900
Latest quarter Q4 2025
13.6KRx
Medicaid pays / ea
$0.2900
gross reimbursed
vs
NADAC / ea
$0.1077
acquisition cost
=
Spread
+$0.1823
+169% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
45% FFS 55% MCO
Fee-for-service · 25,014 Rx Managed care · 29,993 Rx
State Medicaid map
Alaska: no data reported AK Maine: 5,545 units · 397 per 100k residents ME Washington: 24,327 units · 311 per 100k residents WA Idaho: 4,319 units · 220 per 100k residents ID Montana: 2,415 units · 213 per 100k residents MT North Dakota: no data reported ND Minnesota: 33,832 units · 590 per 100k residents MN Wisconsin: 58,908 units · 997 per 100k residents WI Michigan: 110,183 units · 1,098 per 100k residents MI New York: 706,609 units · 3,610 per 100k residents NY Vermont: 10,264 units · 1,586 per 100k residents VT New Hampshire: 8,329 units · 594 per 100k residents NH Oregon: 10,945 units · 259 per 100k residents OR Nevada: 16,920 units · 530 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,800 units · 196 per 100k residents SD Iowa: 10,035 units · 313 per 100k residents IA Illinois: 150,259 units · 1,197 per 100k residents IL Indiana: 43,617 units · 636 per 100k residents IN Ohio: 80,206 units · 681 per 100k residents OH Pennsylvania: 145,375 units · 1,122 per 100k residents PA New Jersey: 101,637 units · 1,094 per 100k residents NJ Massachusetts: 150,742 units · 2,153 per 100k residents MA California: 188,379 units · 483 per 100k residents CA Utah: 6,598 units · 193 per 100k residents UT Colorado: 22,994 units · 391 per 100k residents CO Nebraska: 5,895 units · 298 per 100k residents NE Missouri: 33,403 units · 539 per 100k residents MO Kentucky: 58,700 units · 1,297 per 100k residents KY West Virginia: 20,824 units · 1,176 per 100k residents WV Virginia: 66,448 units · 762 per 100k residents VA Maryland: 75,989 units · 1,230 per 100k residents MD Connecticut: 95,205 units · 2,632 per 100k residents CT Rhode Island: 23,929 units · 2,185 per 100k residents RI Arizona: 34,183 units · 460 per 100k residents AZ New Mexico: 7,155 units · 338 per 100k residents NM Kansas: 3,307 units · 112 per 100k residents KS Arkansas: 2,796 units · 91.2 per 100k residents AR Tennessee: 17,666 units · 248 per 100k residents TN North Carolina: 62,584 units · 578 per 100k residents NC South Carolina: 14,410 units · 268 per 100k residents SC Delaware: 7,615 units · 739 per 100k residents DE Oklahoma: 14,949 units · 369 per 100k residents OK Louisiana: 37,120 units · 812 per 100k residents LA Mississippi: 2,280 units · 77.6 per 100k residents MS Alabama: 2,581 units · 50.5 per 100k residents AL Georgia: 15,199 units · 138 per 100k residents GA D.C.: 14,311 units · 2,108 per 100k residents DC Hawaii: 3,035 units · 211 per 100k residents HI Texas: 16,987 units · 55.7 per 100k residents TX Florida: 43,232 units · 191 per 100k residents FL
Units reimbursed · per 100k residents
50.53,610
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 3,610 /100k
2 Connecticut 2,632 /100k
3 Rhode Island 2,185 /100k
4 Massachusetts 2,153 /100k
5 D.C. 2,108 /100k
6 Vermont 1,586 /100k
7 Kentucky 1,297 /100k
8 Maryland 1,230 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 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.
90 tablets this page57237-0114-90 55,007 Rx · $746,474
100 tablets57237-0114-01 No Medicaid data
500 tablets57237-0114-05 No Medicaid data
Drug total (last 4 qtrs): 55,007 Rx · 2,574,371 units · $746,474 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Alfuzosin Hydrochloride — the ingredient across all brands.

Top reported reactions

Drug Interaction102
Dyspnoea94
Fatigue94
Acute Kidney Injury87
Dizziness77
Diarrhoea76
Hypotension74

Age at onset

Child3
Adult115
Elderly400

Reporter sex

0 reports

Serious outcomes

Hospitalization1,084
Life-threatening167
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 415 149
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
57237-0114-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-01) — — 2012-08-30 Active
57237-0114-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-05) — — 2012-08-30 Active
57237-0114-90 You're viewing this 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (57237-114-90) $0.1077 / ea $9.69 2012-08-30 Active

You're viewing the smallest of 3 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 57237-0114-90?
NDC 57237-0114-90 is a 90-count package — 90 tablet, film coated, extended release in 1 bottle.
What is the difference between NDC 57237-0114-90 and NDC 57237-0114-01?
Both are Alfuzosin Hydrochloride 10 mg Tablet, Film Coated, Extended Release — the drug itself is identical. NDC 57237-0114-90 is the 90-count package, while NDC 57237-0114-01 is the 100 tablets package.
What NDC number is used to bill for this package of Alfuzosin Hydrochloride 10 mg Tablet, Film Coated, Extended Release?
Bill NDC 57237-0114-90 — the 11-digit billing format is 57237011490. 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.

📄 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 108 words ▾

1 INDICATIONS AND USAGE Alfuzosin hydrochloride extended-release tablets are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. (1) Important Limitations of Use: Alfuzosin hydrochloride extended-release tablets are not indicated for treatment of hypertension.

(1.1) Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. (1.1 , 8.4 , 12.3 )

1.1Important Limitations of Use Alfuzosin hydrochloride extended-release tablets are not indicated for the treatment of hypertension. Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population.

⏱️ Dosage and Administration 78 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage is one 10 mg alfuzosin hydrochloride extended-release tablet once daily. The extent of absorption of alfuzosin is 50% lower under fasting conditions. Therefore, alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day.

The tablets should not be chewed or crushed. 10 mg once daily with food and with the same meal each day. (2) Tablets should not be chewed or crushed (2 , 12.3)

💊 Dosage Forms and Strengths 36 words ▾

3 DOSAGE FORMS AND STRENGTHS Alfuzosin hydrochloride extended-release tablets USP 10 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ‘X’ on one side and ‘23’ on other side. Extended-release tablet: 10 mg (3)

⛔ Contraindications 138 words ▾

4 CONTRAINDICATIONS Alfuzosin hydrochloride extended-release tablets are contraindicated for use: in patients with moderate or severe hepatic impairment (Childs-Pugh categories B and C), since alfuzosin blood levels are increased in these patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] . with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ] . in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochloride extended-release tablets [see Adverse Reactions (6.2) ] Moderate or severe hepatic impairment (4 , 8.7 , 12.3) Co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) (4 , 5.4 , 7.1 , 12.3) Known hypersensitivity (e.g., urticaria or angioedema) to alfuzosin or any of the ingredients (4 , 6.2)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Postural hypotension/syncope: Care should be taken in patients with symptomatic hypotension or who have had a hypotensive response to other medications or are concomitantly treated with antihypertensive medication or nitrates (5.1) Use with caution in patients with severe renal impairment (creatinine clearance <30 mL/min) (5.2 , 8.6 , 12.3) Use with caution in patients with mild hepatic impairment (5.3 , 8.7 , 12.3) Should not be used in combination with other alpha adrenergic antagonists (5.4 , 7.2) Prostate carcinoma should be ruled out prior to treatment (5.5) Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery may require modifications to the surgical technique (5.6) Discontinue alfuzosin hydrochloride extended-release tablets if symptoms of angina pectoris appear or worsen (5.8) Use with caution in patients with a history of QT prolongation or who are taking medications which prolong the QT interval (5.9 , 12.2)

5.1Postural Hypotension Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of alfuzosin hydrochloride extended-release tablets. As with other alpha adrenergic antagonists, there is a potential for syncope. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur.

There may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride extended-release tablets concomitantly with anti-hypertensive medication and nitrates. Care should be taken when alfuzosin hydrochloride extended-release tablets are administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.

5.2Patients with Renal Impairment Caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered in patients with severe renal impairment (creatinine clearance < 30 mL/min) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

5.3Patients with Hepatic Impairment Alfuzosin hydrochloride extended-release tablets are contraindicated for use in patients with moderate or severe hepatic impairment [see Contraindications (4) , Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ]. Although the pharmacokinetics of alfuzosin hydrochloride extended-release tablets have not been studied in patients with mild hepatic impairment, caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered to such patients [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] .

5.4Drug-Drug Interactions Potent CYP3A4 Inhibitors: Alfuzosin hydrochloride extended-release tablets are contraindicated for use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) since alfuzosin blood levels are increased [see Contraindications (4) , Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Other alpha adrenergic antagonists: Alfuzosin hydrochloride extended-release tablets are an alpha adrenergic antagonist and should not be used in combination with other alpha adrenergic antagonist [see Drug Interactions (7.2) ].

Phosphodiesterase-5 (PDE5) Inhibitors: PDE5-inhibitors are also vasodilators. Caution is advised for concomitant use of PDE5-inhibitors and alfuzosin hydrochloride extended-release tablets, as this combination can potentially cause symptomatic hypotension [see Drug Interactions (7.4) ].

5.5Prostatic Carcinoma Carcinoma of the prostate and benign prostatic hyperplasia (BPH) cause many of the same symptoms. These two diseases frequently coexist. Therefore, patients thought to have BPH should be examined to rule out the presence of carcinoma of the prostate prior to starting treatment with alfuzosin hydrochloride extended-release tablets.

5.6Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been observed during cataract surgery in s…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions in clinical studies (incidence ≥2% and at a higher incidence than placebo): dizziness, upper respiratory tract infection, headache, fatigue. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 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 clinical practice. The incidence of adverse reactions has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received alfuzosin hydrochloride extended-release tablets 10 mg.

In these trials, 4% of patients taking alfuzosin hydrochloride extended-release tablets 10 mg withdrew from the trial due to adverse reactions, compared with 3% in the placebo group. Table 1 summarizes adverse reactions that occurred in ≥2% of patients receiving alfuzosin hydrochloride extended-release tablets, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.

Table 1 — Adverse Reactions Occurring in ≥2% of Alfuzosin Hydrochloride Extended-Release Tablets-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials Adverse Reaction Placebo (n=678) Alfuzosin Hydrochloride Extended-Release Tablets (n=473) Dizziness 19 (2.8%) 27 (5.7%) Upper respiratory tract infection 4 (0.6%) 14 (3%) Headache 12 (1.8%) 14 (3%) Fatigue 12 (1.8%) 13 (2.7%) The following adverse reactions, reported by between 1% and 2% of patients receiving alfuzosin hydrochloride extended-release tablets and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system: Body as a whole: pain Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea Reproductive system: impotence Respiratory system: bronchitis, sinusitis, pharyngitis Signs and Symptoms of Orthostasis in Clinical Trials: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 trials with alfuzosin 10 mg are summarized in Table 2.

Approximately 20% to 30% of patients in these trials were taking antihypertensive medication. Table 2 — Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Trials Symptoms Placebo (n=678) Alfuzosin Hydrochloride Extended-Release Tablets (n=473) Dizziness 19 (2.8%) 27 (5.7%) Hypotension or postural hypotension 0 2 (0.4%) Syncope 0 1 (0.2%) Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure (≤90 mm Hg, with a decrease ≥20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 alfuzosin hydrochloride extended-release tablets patients.

Decreased diastolic blood pressure (≤50 mm Hg, with a decrease ≥15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the alfuzosin hydrochloride extended-release tablets patients. A positive orthostatic test (decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the alfuzosin hydrochloride extended-release tablets patients.

6.2Post-Marketing Experience The following adverse reactions have been identified during post approval use of alfuzosin hydrochloride extended-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequenc…

🔄 Drug Interactions 205 words ▾

7 DRUG INTERACTIONS Concomitant use of PDE5 inhibitors with alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, can potentially cause symptomatic hypotension (5.4 , 7.4)

7.1CYP3A4 Inhibitors Alfuzosin hydrochloride extended-release tablets are contraindicated for use with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, or ritonavir, since alfuzosin blood levels are increased [see Contraindications (4) , Warnings and Precautions (5.4) and Clinical Pharmacology (12.3) ] .

7.2Alpha Adrenergic Antagonists The pharmacokinetic and pharmacodynamic interactions between alfuzosin hydrochloride extended-release tablets and other alpha adrenergic antagonists have not been determined. However, interactions may be expected, and alfuzosin hydrochloride extended-release tablets should not be used in combination with other alpha adrenergic antagonists [see Warnings and Precautions (5.4) ] .

7.3Antihypertensive Medication and Nitrates There may be an increased risk of hypotension/postural hypotension and syncope when taking alfuzosin hydrochloride extended-release tablets concomitantly with anti-hypertensive medication and nitrates [see Warnings and Precautions (5.1) ] .

7.4PDE5 Inhibitors Caution is advised when alpha adrenergic antagonists, including alfuzosin hydrochloride extended-release tablets, are coadministered with PDE5 inhibitors. Alpha adrenergic antagonists and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension [see Warnings and Precautions (5.4) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Alfuzosin hydrochloride extended-release tablets are not indicated for use in women. There are no adequate data on the developmental risk associated with use of alfuzosin hydrochloride extended-release tablets in pregnant women. Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at up to 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbits, via body surface area.

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancy is 2 to 4% and 15 to 20%, respectively. Data Animal data Alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on AUC of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (MRHD) of 10 mg. In rabbits administered up to 3 times the MRHD (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed.

Gestation was slightly prolonged in rats at exposure levels (based on AUC of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the MRHD, but difficulties with parturition were not observed.

8.2Lactation Risk Summary Alfuzosin hydrochloride extended-release tablets are not indicated for use in women. There are no data on the presence of alfuzosin hydrochloride in human milk, the effect on the breastfed child, or effect on milk production.

8.4Pediatric Use Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. Efficacy of alfuzosin hydrochloride was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years with elevated detrusor leak point pressure (LPP≥40 cm H 2 O) of neurologic origin treated with alfuzosin hydrochloride using pediatric formulations. The trial included a 12-week efficacy phase followed by a 40-week safety extension period.

No statistically significant difference in the proportion of patients achieving a detrusor leak point pressure of <40 cm H 2 O was observed between the alfuzosin and placebo groups. During the placebo-controlled trial, the adverse reactions reported in ≥2% of patients treated with alfuzosin and at a higher incidence than in the placebo group were: pyrexia, headache, respiratory tract infection, cough, epistaxis and diarrhea. The adverse reactions reported for the whole 12-month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the 12-week period.

Alfuzosin hydrochloride was not studied in patients below the age of 2.

8.5Geriatric Use Of the total number of subjects in clinical studies of alfuzosin hydrochloride extended-release tablets, 48% were 65 years of age and over, whereas 11% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) ]

8.6Renal Impairment Systemic exposure was increased by approximately 50% in pharmacokinetic studies of patients with mild, moderate, and severe renal impairment [see Clinical Pharmacology (12.3) ] . In phase 3 studies, the safety profile of patients with mild (n=172) or moderate (n=56) renal impairment was similar to the patients with normal renal function in those studies. Safety data are available in only a limited number of patients (n=6) with creatinine clearance below 30 mL/min; therefore, caution should be exercised when alfuzosin hydrochloride extended-release tablets are administered in patients with severe renal impairment [see Warnings and Precautions (5.2) ] .

8.7 Hepatic Impairment The pharmacokinetics of alfuzosin hydrochloride extend…

🤰 Pregnancy 208 words ▾

8.1Pregnancy Risk Summary Alfuzosin hydrochloride extended-release tablets are not indicated for use in women. There are no adequate data on the developmental risk associated with use of alfuzosin hydrochloride extended-release tablets in pregnant women. Based on findings from animal studies, alfuzosin administered during the period of organogenesis was not teratogenic, embryotoxic or fetotoxic at up to 1200 times the MRHD of 10 mg via AUC in rats and 3 times in rabbits, via body surface area.

In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancy is 2 to 4% and 15 to 20%, respectively. Data Animal data Alfuzosin was not teratogenic, embryotoxic or fetotoxic in rats at plasma exposure levels (based on AUC of unbound drug) up to 1200 times (maternal oral dose of 250 mg/kg/day) the maximum recommended human dose (MRHD) of 10 mg. In rabbits administered up to 3 times the MRHD (based on body surface area) (maternal oral dose of 100 mg/kg/day) no embryofetal toxicity or teratogenicity was observed.

Gestation was slightly prolonged in rats at exposure levels (based on AUC of unbound drug) approximately 12 times (greater than 5 mg/kg/day oral maternal dose) the MRHD, but difficulties with parturition were not observed.

🧒 Pediatric Use 181 words ▾

8.4Pediatric Use Alfuzosin hydrochloride extended-release tablets are not indicated for use in the pediatric population. Efficacy of alfuzosin hydrochloride was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years with elevated detrusor leak point pressure (LPP≥40 cm H 2 O) of neurologic origin treated with alfuzosin hydrochloride using pediatric formulations. The trial included a 12-week efficacy phase followed by a 40-week safety extension period.

No statistically significant difference in the proportion of patients achieving a detrusor leak point pressure of <40 cm H 2 O was observed between the alfuzosin and placebo groups. During the placebo-controlled trial, the adverse reactions reported in ≥2% of patients treated with alfuzosin and at a higher incidence than in the placebo group were: pyrexia, headache, respiratory tract infection, cough, epistaxis and diarrhea. The adverse reactions reported for the whole 12-month trial period, which included the open-label extension, were similar in type and frequency to the reactions observed during the 12-week period.

Alfuzosin hydrochloride was not studied in patients below the age of 2.

🧓 Geriatric Use 62 words ▾

8.5Geriatric Use Of the total number of subjects in clinical studies of alfuzosin hydrochloride extended-release tablets, 48% were 65 years of age and over, whereas 11% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) ]

🆘 Overdosage 87 words ▾

10 OVERDOSAGE Should overdose of alfuzosin hydrochloride extended-release tablets lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, then the administration of intravenous fluids should be considered.

If necessary, vasopressors should then be used, and the renal function should be monitored and supported as needed. Alfuzosin is 82% to 90% protein bound; therefore, dialysis may not be of benefit.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Alfuzosin is a selective antagonist of post-synaptic alpha 1 -adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

12.2Pharmacodynamics Alfuzosin exhibits selectivity for alpha adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors can cause smooth muscle in the bladder neck and prostate to relax, resulting in an improvement in urine flow and a reduction in symptoms of BPH. Cardiac Electrophysiology The effect of 10 mg and 40 mg alfuzosin on QT interval was evaluated in a double-blind, randomized, placebo and active-controlled (moxifloxacin 400 mg), 4-way crossover single dose study in 45 healthy white male subjects aged 19 to 45 years.

The QT interval was measured at the time of peak alfuzosin plasma concentrations. The 40 mg dose of alfuzosin was chosen because this dose achieves higher blood levels than those achieved with the co-administration of alfuzosin hydrochloride extended-release tablets and ketoconazole 400 mg. Table 3 summarizes the effect on uncorrected QT and mean corrected QT interval (QTc) with different methods of correction (Fridericia, population-specific and subject-specific correction methods) at the time of peak alfuzosin plasma concentrations.

No single one of these correction methodologies is known to be more valid. The mean change of heart rate associated with a 10 mg dose of alfuzosin in this study was 5.2 beats/minute and 5.8 beats/minute with 40 mg alfuzosin. The change in heart rate with moxifloxacin was 2.8 beats/minute.

Table 3. Mean QT and QTc changes in msec (95% CI) from baseline at T max (relative to placebo) with different methodologies to correct for effect of heart rate. *Active control Drug/Dose QT Fridericia method Population- specific method Subject- specific method Alfuzosin 10 mg -5.8 (-10.2, -1.4) 4.9 (0.9, 8.8) 1.8 (-1.4, 5) 1.8 (-1.3, 5) Alfuzosin 40 mg -4.2 (-8.5, 0.2) 7.7 (1.9, 13.5) 4.2 (-0.6, 9) 4.3 (-0.5, 9.2) Moxifloxacin* 400 mg 6.9 (2.3, 11.5) 12.7 (8.6, 16.8) 11 (7, 15) 11.1 (7.2, 15) The QT effect appeared greater for 40 mg compared to 10 mg alfuzosin.

The effect of the highest alfuzosin dose (four times the therapeutic dose) studied did not appear as large as that of the active control moxifloxacin at its therapeutic dose. This study, however, was not designed to make direct statistical comparisons between the drugs or the dose levels. There has been no signal of Torsade de Pointes in the extensive post-marketing experience with alfuzosin outside the United States.

A separate post-marketing QT study evaluated the effect of the co-administration of 10 mg alfuzosin with a drug of similar QT effect size. In this study, the mean placebo-subtracted QTcF increase of alfuzosin 10 mg alone was 1.9 msec (upperbound 95% CI, 5.5 msec). The concomitant administration of the two drugs showed an increased QT effect when compared with either drug alone.

This QTcF increase [5.9 msec (UB 95% CI, 9.4 msec)] was not more than additive. Although this study was not designed to make direct statistical comparisons between drugs, the QT increase with both drugs given together appeared to be lower than the QTcF increase seen with the positive control moxifloxacin 400 mg [10.2 msec (UB 95% CI, 13.8 msec)]. The clinical impact of these QTc changes is unknown.

12.3Pharmacokinetics The pharmacokinetics of alfuzosin hydrochloride extended-release tablets have been evaluated in adult healthy male volunteers after single and/or multiple administration with daily doses ranging from 7.5 mg to 30 mg, and in patients with BPH at doses from 7.5 mg to 15 mg. Absorption The absolute bioavailability of alfuzosin hydrochloride extended-release tablets 10 mg under fed conditions is 49%. Following multiple dosing of 10 mg alfuzosin hydrochloride extended-release tablets under fed conditions, the time to maximum concentration is 8 hours.

C max and AUC 0-24 are 13.6 (…

🧬 Mechanism of Action 29 words ▾

12.1Mechanism of Action Alfuzosin is a selective antagonist of post-synaptic alpha 1 -adrenoreceptors, which are located in the prostate, bladder base, bladder neck, prostatic capsule, and prostatic urethra.

📦 How Supplied / Storage and Handling 94 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Alfuzosin Hydrochloride Extended-Release Tablets USP, 10 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ‘X’ on one side and ‘23’ on other side. Bottles of 90 NDC 57237-114-90 Bottles of 100 NDC 57237-114-01 Bottles of 500 NDC 57237-114-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as described in the USP.

Protect from light and moisture. Keep alfuzosin hydrochloride extended-release tablets out of reach of children.

📋 Description 119 words ▾

11 DESCRIPTION Each alfuzosin hydrochloride extended-release tablet USP contains 10 mg alfuzosin hydrochloride USP as the active ingredient. Alfuzosin hydrochloride USP is a white to off-white crystalline powder that melts at approximately 240°C. It is freely soluble in water, sparingly soluble in alcohol, and practically insoluble in dichloromethane.

Alfuzosin hydrochloride is (R,S)-N-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl) methylamino] propyl] tetrahydro-2-furancarboxamide hydrochloride. The molecular formula of alfuzosin hydrochloride is C 19 H 27 N 5 O 4 •HCl. The molecular weight of alfuzosin hydrochloride is 425.9.

Its structural formula is: The tablet also contains the following inactive ingredients: carbomer, colloidal silicon dioxide, dibasic calcium phosphate anhydrous, hydrogenated vegetable oil, hypromellose, magnesium stearate, povidone, propylene glycol, and titanium dioxide. Meets USP Dissolution Test 5. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling .

17.1Hypotension/Syncope Patients should be told about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when beginning alfuzosin hydrochloride extended-release tablets, and they should be cautioned about driving, operating machinery, or performing hazardous tasks during this period. This is important for those with low blood pressure or who are taking antihypertensive medications or nitrates [see Warnings and Precautions (5.1) ] .

17.2Intraoperative Floppy Iris Syndrome Patients should be instructed to tell their ophthalmologist about their use of alfuzosin hydrochloride extended-release tablets before cataract surgery or other procedures involving the eyes, even if the patient is no longer taking alfuzosin hydrochloride extended-release tablets [see Warnings and Precautions (5.6) ] .

17.3Priapism Patients should be advised about the possibility of priapism resulting from treatment with alfuzosin hydrochloride extended-release tablets and medications in the same class. Although this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [see Warnings and Precautions (5.7) ] .

17.4Instructions of Use Alfuzosin hydrochloride extended-release tablets should be taken with food and with the same meal each day. Patients should be advised not to crush or chew alfuzosin hydrochloride extended-release tablets. The full text of the patient information is reprinted at the end of this document. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Made in India Code: TS/DRUGS/19/1993 Revised: 12/2025

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