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Finasteride 5 mg Tablet, Film Coated, 30-count — NDC 71610-0520-30 package photo

Finasteride 5 mg Tablet, Film Coated, 30-count

by Aphena Pharma Solutions - Tennessee, LLC · 30 TABLET, FILM COATED in 1 BOTTLE (71610-520-30)
NDC 71610-0520-30
🏷️ FDA NDC (as labeled) 71610-520-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.2017/unit — full pricing hub ↓
Also comes in: 90 tablets 71610-0520-60
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) 71610-520-30
Product NDC 71610-520
11-digit billing NDC 71610052030
NCPDP billing unit EA — each (per item)
RxCUI 310346
UNII 57GNO57U7G
Application # ANDA204304
SPL Set ID 845cad9c-c50d-4c98-8df8-893d1241836a
Established class (EPC) 5-alpha Reductase Inhibitor
Mechanism of action 5-alpha Reductase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-01-05
Route ORAL
Dosage form TABLET, FILM COATED
Substance FINASTERIDE
GPI-14 56851030000320
GPI class Finasteride
GCN Seq No 041440
GCN 30521
HICL code 006421
Ingredient (HICL) Finasteride
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 84:16.00.00
AHFS class Cell Stimulants And Proliferants
FDB label name FINASTERIDE 5 MG TABLET
FDB brand name Finasteride
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 71610-520-30 — 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 → 71610-0520-30. 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 5-alpha Reductase Inhibitor class.

Pharmacologic class 5-alpha Reductase Inhibitor
Drug family (ATC) Other dermatologicals, Testosterone-5-alpha reductase inhibitors
How it works 5-alpha Reductase 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

LabelerAphena Pharma Solutions - Tennessee, LLC
Application holderALKEM LABORATORIES LTD
FDA applicationANDA204304 (ANDA)
Labeler code71610
First marketedJan 2017
Product typeHuman Prescription Drug
Portfolio795 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 FINASTERIDE 5 MG TABLET Ingredient Finasteride
📖 What it is MedlinePlus · NLM

Finasteride is used to treat benign prostatic hypertrophy (BPH, enlargement of the prostate gland) and male pattern hair loss (gradual thinning of the hair on the scalp, leading to a receding hairline or balding on the top of the head in men). Finasteride is in a class of medications called 5-alpha reductase inhibitors. Finasteride treats BPH by blocking the body's production of a male hormone that causes the prostate to enlarge. Finasteride treats male pattern hair loss by blocking the body's production of a male hormone in the scalp that stops hair growth.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Finasteride is used for two different conditions in men, and the brand matters. Proscar (the higher-strength tablet) is prescribed for an enlarged prostate (BPH) to ease urinary sy...
  • What exactly is finasteride used for — and which brand should I be taking?
  • It depends on what you're treating. For hair loss with Propecia, you generally need at least three months of daily use before noticing a difference — and you need to keep taking it...
  • How long will it take before I see results?
📖 Read our full Finasteride 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 Blue
ShapeRound
ImprintF5
Size7 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 L06K8R7DQK
    A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

9 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 $0.2017 $6.05 / 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
Finasteride 5 mg 00093-7355-05 Teva 500 tablets $0.068 AB Availability likely —
Finasteride 5 mg 00904-6830-06 Major 1 tablet $0.068 AB Availability likely —
Finasteride 5 mg 43598-0303-30 Dr 30 tablets $0.068 AB Availability likely —
Finasteride 5 mg 50268-0314-15 AvPAK 1 tablet $0.068 AB Availability likely —
Finasteride 5 mg 57237-0062-05 Rising 500 tablets $0.068 AB Availability likely —
Finasteride 5 mg 60687-0428-01 American 1 tablet $0.068 AB Availability likely —
Finasteride 5 mg 65862-0149-01 Aurobindo 100 tablets $0.068 AB Availability likely —
Finasteride 5 mg 68645-0541-54 Legacy 30 tablets $0.068 AB Availability likely —
Finasteride 5 mg 76282-0412-05 Exelan 500 tablets $0.068 AB Availability likely —
Finasteride 5 mg 82009-0061-05 QUALLENT 500 tablets $0.068 AB Availability likely —
Finasteride 5 mg 16729-0090-01 Accord 100 tablets $0.069 AB Availability likely —
Proscar 5 mg 78206-0153-01 Organon 30 tablets $5.707 AB Availability likely —
Finasteride 5 mg 00615-8562-05 NCS 15 tablets — AB FDA listed —
Finasteride 5 mg 17856-0090-01 Atlantic 1 tablet — AB FDA listed —
Finasteride 5 mg 31722-0525-01 Camber 100 tablets — AB FDA listed —
Finasteride 5 mg 50090-1936-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 50090-4697-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 50090-6940-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 50090-6941-00 A-S 90 tablets — AB FDA listed —
Finasteride 5 mg 50090-7086-00 A-S 90 tablets — AB FDA listed —
Finasteride 5 mg 50090-7228-00 A-S 30 tablets — AB FDA listed —
Finasteride 5 mg 55111-0172-01 Dr. 100 tablets — AB FDA listed —
Finasteride 5 mg 55154-2639-00 Cardinal 1 tablet — AB FDA listed —
Finasteride 5 mg 55154-8083-00 Cardinal 1 tablet — AB FDA listed —
Finasteride 5 mg 63187-0265-10 Proficient 10 tablets — AB FDA listed —
Finasteride 5 mg 63629-1585-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 67046-1058-03 Coupler 30 tablets — AB FDA listed —
Finasteride 5 mg 67877-0288-01 Ascend 100 tablets — AB FDA listed —
Finasteride 5 mg 68071-2999-09 NuCare 90 tablets — AB FDA listed —
Finasteride 5 mg 68071-3234-09 NuCare 90 tablets — AB FDA listed —
Finasteride 5 mg 68071-3354-09 NuCare 90 tablets — AB FDA listed —
Finasteride 5 mg 68071-3380-03 NuCare 30 tablets — AB FDA listed —
Finasteride 5 mg 68071-3417-03 NuCare 30 tablets — AB FDA listed —
Finasteride 5 mg 68071-3785-02 NuCare 120 tablets — AB FDA listed —
Finasteride 5 mg 68788-8377-01 Preferred 100 tablets — AB FDA listed —
Finasteride 5 mg 68788-8433-01 Preferred 100 tablets — AB FDA listed —
Finasteride 5 mg 68788-8749-01 Preferred 100 tablets — AB FDA listed —
Finasteride 5 mg 70518-1704-02 REMEDYREPACK 1 tablet — AB FDA listed —
Finasteride 5 mg 70518-3182-00 REMEDYREPACK 1 tablet — AB FDA listed —
Finasteride 5 mg 70518-3600-01 REMEDYREPACK 1 tablet — AB FDA listed —
Finasteride 5 mg 70518-3616-00 REMEDYREPACK 30 tablets — AB Discontinued —
Finasteride 5 mg 71205-0767-30 Proficient 30 tablets — AB FDA listed —
Finasteride 5 mg 71335-0433-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71335-1530-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71335-1634-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71335-1898-01 Bryant 100 tablets — AB FDA listed —
Finasteride 5 mg 71610-0515-60 Aphena 90 tablets — AB FDA listed —
Finasteride 5 mgthis 71610-0520-30 Aphena 30 tablets — AB FDA listed —
Finasteride 5 mg 72189-0542-30 Direct_Rx 30 tablets — AB FDA listed —
Finasteride 5 mg 76420-0154-30 Asclemed 30 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

🏛️
2017
On the market since
Jan 2017
📍
2026
Currently FDA-listed
9 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 Finasteride — the program that covers self-administered drugs. 11 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 Finasteride. 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
$25.36M
Claims incl. refills
1.9M
Beneficiaries
1.5M
Spend / beneficiary
$17.05
Spend / claim
$13.15
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71610-0520-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (71610-520-30) 2022-02-22 Active
71610-0520-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-520-60) 2021-01-27 Active

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

Pack size FAQ

What quantity is in NDC 71610-0520-30?
NDC 71610-0520-30 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 71610-0520-30 and NDC 71610-0520-60?
Both are Finasteride 5 mg Tablet, Film Coated — the drug itself is identical. NDC 71610-0520-30 is the 30-count package, while NDC 71610-0520-60 is the 90 tablets package.
What NDC number is used to bill for this package of Finasteride 5 mg Tablet, Film Coated?
Bill NDC 71610-0520-30 — the 11-digit billing format is 71610052030. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 71610-520-30, 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: 71610-0520-30, written without dashes as 71610052030. 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 71610-0520-30, the first segment (71610) is the labeler code FDA assigned to Aphena Pharma Solutions - Tennessee, LLC; the middle segment (0520) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) 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 Aphena Pharma Solutions - Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 90 tablets (71610-0520-60). 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?
Aphena Pharma Solutions - Tennessee, LLC 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 201 words ▾

1 INDICATIONS & USAGE Finasteride Tablets, USP is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to ( 1.1 ): Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride Tablets, USP administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score) ( 1.2 ).

Limitations of Use: Finasteride Tablets, USP are not approved for the prevention of prostate cancer ( 1.3 ).

1.1Monotherapy Finasteride Tablets, USP are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

1.2Combination with Alpha-Blocker Finasteride Tablets, USP administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score).

1.3Limitations of Use Finasteride Tablets, USP are not approved for the prevention of prostate cancer.

⏱️ Dosage and Administration 114 words ▾

2 DOSAGE & ADMINISTRATION Finasteride Tablets, USP may be administered with or without meals. Finasteride Tablets, USP may be administered with or without meals ( 2 ). Monotherapy: One tablet (5 mg) taken once a day ( 2.1 ). Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin ( 2.2 ).

2.1Monotherapy The recommended dose of Finasteride Tablets, USP is one tablet (5 mg) taken once a day [see Clinical Studies (14.1) ].

2.2Combination with Alpha-Blocker The recommended dose of Finasteride Tablets, USP is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [ see Clinical Studies (14.2) ].

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS & STRENGTHS 5 mg blue colored, round, biconvex, film-coated tablets, marked “F5” on one side and plain on other side. 5-mg film-coated tablets ( 3 ).

⛔ Contraindications 169 words ▾

4 CONTRAINDICATIONS Finasteride Tablets, USP is contraindicated in the following: Hypersensitivity to any component of this medication. Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be pregnant.

Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (DHT), finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. [See also Warnings and Precautions (5.3) , Use in Specific Populations (8.1) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2) .] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

Hypersensitivity to any components of this product ( 4 ). Women who are or may potentially be pregnant ( 4 , 5.4 , 8.1 , 16 ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Finasteride Tablets, USP reduces serum prostate specific antigen (PSA) levels by approximately 50%. However, any confirmed increase in PSA while on Finasteride Tablets, USP may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5α-reductase inhibitor ( 5.1 ). Finasteride Tablets, USP may increase the risk of high-grade prostate cancer ( 5.2 , 6.1 ).

Women should not handle crushed or broken Finasteride Tablets, USP when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.3 , 8.1 , 16 ). Finasteride Tablets, USP is not indicated for use in pediatric patients or women ( 5.4 , 8.1 , 8.3 , 8.4 , 12.3 ). Prior to initiating treatment with Finasteride Tablets, USP for BPH, consideration should be given to other urological conditions that may cause similar symptoms ( 5.6 ).

5.1Effects on Prostate Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection In clinical studies, Finasteride Tablets, USP reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals. For interpretation of serial PSAs in men taking Finasteride Tablets, USP, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter.

Any confirmed increase from the lowest PSA value while on Finasteride Tablets, USP may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance with Finasteride Tablets, USP therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with Finasteride Tablets, USP for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.

These adjustments preserve the utility of PSA to detect prostate cancer in men treated with Finasteride Tablets, USP. Finasteride Tablets, USP may also cause decreases in serum PSA in the presence of prostate cancer. The ratio of free to total PSA (percent free PSA) remains constant even under the influence of Finasteride Tablets, USP.

If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no adjustment to its value appears necessary.

5.2Increased Risk of High-Grade Prostate Cancer Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8 to 10 prostate cancer (finasteride 1.8% vs placebo 1.1%). [ See Indications and Usage (1.3) and Adverse Reactions (6.1) ] Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs 0.5% placebo).

5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

5.3Exposure of Women - Risk to Male Fetus Women should not handle crushed or broken Finasteride Tablets, USP when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus. Finasteride Tablets, USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.[ See Contraindications (4) , Use in Specific Populations (8.1) , Clinical Pharmacology (12.3) , How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2) . ]

5.4 Pediatric Patients and Wo…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The drug-related adverse reactions, reported in ≥1% in patients treated with Finasteride Tablets, USP and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Finasteride Tablets, USP is generally well tolerated; adverse reactions usually have been mild and transient. 4-Year Placebo-Controlled Study (A Long-Term Efficacy and Safety Study) In A Long-Term Efficacy and Safety Study, 1524 patients treated with Finasteride Tablets, USP and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function.

3.7% (57 patients) treated with Finasteride Tablets, USP and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions. Table 1 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on Finasteride Tablets, USP was ≥1% and greater than placebo over the 4 years of the study. In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

Table 1: Drug-Related Adverse Experiences Year 1 (%) Years 2, 3 and 4*(%) Finasteride Placebo Finasteride Placebo Impotence 8.1 3.7 5.1

5.1Decreased Libido 6.4 3.4 2.6

2.6Decreased Volume of Ejaculate 3.7 0.8 1.5

0.5Ejaculation Disorder 0.8 0.1 0.2

0.1Breast Enlargement 0.5 0.1 1.8

1.1Breast Tenderness 0.4 0.1 0.7

0.3Rash 0.5 0.2 0.5 0.1 *Combined Years 2 to 4 N = 1524 and 1516, finasteride vs placebo, respectively Phase III Studies and 5-Year Open Extensions The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and A Long-Term Efficacy and Safety Study were similar. Medical Therapy of Prostatic Symptoms (MTOPS) Study In the MTOPS study, 3047 men with symptomatic BPH were randomized to receive Finasteride Tablets, USP 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of Finasteride Tablets, USP 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737) for 4 to 6 years. [See Clinical Studies (14.2) .] The incidence rates of drug-related adverse experiences reported by ≥2% of patients in any treatment group in the MTOPS Study are listed in Table 2.

The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 2). Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies. Combination therapy with finasteride and doxazosin was associated with no new clinical adverse experience.

Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on finasteride only and one was on combination therapy. [See Long Term Data.] The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences. In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.

Adverse Experience Placebo (N=737) (%) Doxazosin 4 mg or 8 mg* (N=756) (%) Finasteride (N=768) (%…

🔄 Drug Interactions 115 words ▾

7 DRUG INTERACTIONS

7.1Cytochrome P450-Linked Drug Metabolizing Enzyme System No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically meaningful interactions were found.

7.2Other Concomitant Therapy Although specific interaction studies were not performed, Finasteride Tablets, USP was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, H 2 antagonists and quinolone anti-infectives without evidence of clinically significant adverse interactions.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Category X. [See Contraindications (4) .] Finasteride Tablets, USP is contraindicated for use in women who are or may become pregnant. Finasteride is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency.

Women could be exposed to finasteride through contact with crushed or broken Finasteride Tablets, USP or semen from a male partner taking Finasteride Tablets, USP. With regard to finasteride exposure through the skin, Finasteride Tablets, USP are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Women who are pregnant or may become pregnant should not handle crushed or broken Finasteride Tablets, USP because of possible exposure of a male fetus.

If a pregnant woman comes in contact with crushed or broken Finasteride Tablets, USP, the contact area should be washed immediately with soap and water. With regard to potential finasteride exposure through semen, two studies have been conducted in men receiving Finasteride Tablets, USP 5 mg/day that measured finasteride concentrations in semen [ see Clinical Pharmacology (12.3) ]. In an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis (gestation days 6 to 17).

At maternal doses of oral finasteride approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia.

At oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). No abnormalities were observed in female offspring at any maternal dose of finasteride.

No developmental abnormalities were observed in the offspring of untreated females mated with finasteride treated male rats that received approximately 61 times the MRHD (based on AUC at animal dose of 80 mg/kg/day). Slightly decreased fertility was observed in male offspring after administration of about 3 times the MRHD (based on AUC at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation. No effects on fertility were seen in female offspring under these conditions.

No evidence of male external genital malformations or other abnormalities were observed in rabbit fetuses exposed to finasteride during the period of major organogenesis (gestation days 6 to 18) at maternal oral doses up to 100 mg/kg /day, (finasteride exposure levels were not measured in rabbits). However, this study may not have included the critical period for finasteride effects on development of male external genitalia in the rabbit. The fetal effects of maternal finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (g…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Category X. [See Contraindications (4) .] Finasteride Tablets, USP is contraindicated for use in women who are or may become pregnant. Finasteride is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, finasteride caused abnormal development of external genitalia in male fetuses.

If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus. Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency.

Women could be exposed to finasteride through contact with crushed or broken Finasteride Tablets, USP or semen from a male partner taking Finasteride Tablets, USP. With regard to finasteride exposure through the skin, Finasteride Tablets, USP are coated and will prevent skin contact with finasteride during normal handling if the tablets have not been crushed or broken. Women who are pregnant or may become pregnant should not handle crushed or broken Finasteride Tablets, USP because of possible exposure of a male fetus.

If a pregnant woman comes in contact with crushed or broken Finasteride Tablets, USP, the contact area should be washed immediately with soap and water. With regard to potential finasteride exposure through semen, two studies have been conducted in men receiving Finasteride Tablets, USP 5 mg/day that measured finasteride concentrations in semen [ see Clinical Pharmacology (12.3) ]. In an embryo-fetal development study, pregnant rats received finasteride during the period of major organogenesis (gestation days 6 to 17).

At maternal doses of oral finasteride approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia.

At oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). No abnormalities were observed in female offspring at any maternal dose of finasteride.

No developmental abnormalities were observed in the offspring of untreated females mated with finasteride treated male rats that received approximately 61 times the MRHD (based on AUC at animal dose of 80 mg/kg/day). Slightly decreased fertility was observed in male offspring after administration of about 3 times the MRHD (based on AUC at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation. No effects on fertility were seen in female offspring under these conditions.

No evidence of male external genital malformations or other abnormalities were observed in rabbit fetuses exposed to finasteride during the period of major organogenesis (gestation days 6 to 18) at maternal oral doses up to 100 mg/kg /day, (finasteride exposure levels were not measured in rabbits). However, this study may not have included the critical period for finasteride effects on development of male external genitalia in the rabbit. The fetal effects of maternal finasteride exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20 to 100), in a…

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use Finasteride Tablets, USP is not indicated for use in pediatric patients. Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 79 words ▾

8.5Geriatric Use Of the total number of subjects included in A Long-Term Efficacy and Safety Study, 1480 and 105 subjects were 65 and over and 75 and over, respectively. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly [see Clinical Pharmacology (12.3) and Clinical Studies (14)] .

🆘 Overdosage 92 words ▾

10 OVERDOSAGE Patients have received single doses of Finasteride Tablets, USP up to 400 mg and multiple doses of Finasteride Tablets, USP up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with Finasteride Tablets, USP can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m 2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m 2 (400 mg/kg) and 5900 mg/m 2 (1000 mg/kg), respectively.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α -dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t ½ ~ 30 days). This has been demonstrated both in vivo and in vitro .

Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.

12.2Pharmacodynamics In man, a single 5-mg oral dose of Finasteride Tablets, USP produces a rapid reduction in serum DHT concentration, with the maximum effect observed 8 hours after the first dose. The suppression of DHT is maintained throughout the 24-hour dosing interval and with continued treatment. Daily dosing of Finasteride Tablets, USP at 5 mg/day for up to 4 years has been shown to reduce the serum DHT concentration by approximately 70%.

The median circulating level of testosterone increased by approximately 10 to 20% but remained within the physiologic range. In a separate study in healthy men treated with finasteride 1 mg per day (n=82) or placebo (n=69), mean circulating levels of testosterone and estradiol were increased by approximately 15% as compared to baseline, but these remained within the physiologic range. In patients receiving Finasteride Tablets, USP 5 mg/day, increases of about 10% were observed in luteinizing hormone (LH) and follicle-stimulating hormone (FSH), but levels remained within the normal range.

In healthy volunteers, treatment with Finasteride Tablets, USP did not alter the response of LH and FSH to gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not affected. In patients with BPH, Finasteride Tablets, USP has no effect on circulating levels of cortisol, prolactin, thyroid-stimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides) or bone mineral density.

Adult males with genetically inherited Type II 5α -reductase deficiency also have decreased levels of DHT. Except for the associated urogenital defects present at birth, no other clinical abnormalities related to Type II 5α -reductase deficiency have been observed in these individuals. These individuals have a small prostate gland throughout life and do not develop BPH.

In patients with BPH treated with finasteride (1 to 100 mg/day) for 7 to 10 days prior to prostatectomy, an approximate 80% lower DHT content was measured in prostatic tissue removed at surgery, compared to placebo; testosterone tissue concentration was increased up to 10 times over pretreatment levels, relative to placebo. Intraprostatic content of PSA was also decreased. In healthy male volunteers treated with Finasteride Tablets, USP for 14 days, discontinuation of therapy resulted in a return of DHT levels to pretreatment levels in approximately 2 weeks.

In patients treated for three months, prostate volume, which declined by approximately 20%, returned to close to baseline value after approximately three months of discontinuation of therapy.

12.3Pharmacokinetics Absorption In a study of 15 healthy young subjects, the mean bioavailability of finasteride 5-mg tablets was 63% (range 34 to 108%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV) reference dose. Maximum finasteride plasma concentration averaged 37 ng/mL (range, 27 to 49 ng/mL) and was reached 1 to 2 hours postdose. Bioavailability of finasteride was not affected by food.

Distribution Mean steady-state volume of distribution w…

🧬 Mechanism of Action 118 words ▾

12.1Mechanism of Action The development and enlargement of the prostate gland is dependent on the potent androgen, 5α -dihydrotestosterone (DHT). Type II 5α-reductase metabolizes testosterone to DHT in the prostate gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei of these organs.

Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a stable enzyme complex. Turnover from this complex is extremely slow (t ½ ~ 30 days). This has been demonstrated both in vivo and in vitro .

Finasteride has no affinity for the androgen receptor. In man, the 5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.

📦 How Supplied / Storage and Handling 144 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Finasteride Tablets, USP 5 mg are available as blue colored, 7 mm round, biconvex, film coated tablets, marked “F5” on one side and plain on other side. NDC 67877-288-30, bottles of 30 tablets NDC 67877-288-90, bottles of 90 tablets NDC 67877-288-01, bottles of 100 tablets NDC 67877-288-05, bottles of 500 tablets NDC 67877-288-10, bottles of 1000 tablets Storage and Handling Store at room temperatures below 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light and keep container tightly closed.

Women should not handle crushed or broken Finasteride Tablets, USP when they are pregnant or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male fetus [see Warnings and Precautions (5.3 ), Use in Specific Populations (8.1 ) and Patient Counseling Information (17.2) ] .

📋 Description 141 words ▾

11 DESCRIPTION Finasteride, a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II 5α -reductase, an intracellular enzyme that converts the androgen testosterone into 5α -dihydrotestosterone (DHT). Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1, 1-dimethylethyl)-3-oxo-, (5α , 17ß)-. The empirical formula of finasteride is C 23 H 36 N 2 O 2 and its molecular weight is 372.55.

Its structural formula is: Finasteride USP is a white crystalline powder with a melting point near 250°C. It is freely soluble in chloroform and in lower alcohol solvents, but is practically insoluble in water. Finasteride Tablets, USP for oral administration are film-coated tablets that contain 5 mg of finasteride and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, lauroylmacrogol 32 Glycer, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and FD & C blue #2/indigo carmine aluminium lake.

Structutre

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling (Patient Information).

17.1Increased Risk of High-Grade Prostate Cancer Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including Finasteride Tablets, USP compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Indications and Usage (1.3) , Warnings and Precautions (5.2), and Adverse Reactions (6.1) ] .

17.2Exposure of Women-Risk to Male Fetus Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken Finasteride Tablets, USP because of the possibility of absorption of finasteride and the subsequent potential risk to the male fetus. Finasteride Tablets, USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken Finasteride Tablets, USP, the contact area should be washed immediately with soap and water [see Contraindications (4) , Warnings and Precautions (5.3) , Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

17.3Additional Instructions Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with Finasteride Tablets, US . This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with Finasteride Tablets, USP [see Adverse Reactions ( 6.1 ) ] Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge.

Breast changes including breast enlargement, tenderness and neoplasm have been reported [see Adverse Reactions ( 6.1 ) ] . Physicians should instruct their patients to read the patient package insert before starting therapy with Finasteride Tablets, USP and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding Finasteride Tablets, USP. Trademarks are the property of their respective owners.

Manufactured in India by: Alkem Laboratories Limited H.O.: ALKEM HOUSE, Senapati Bapat Marg, Lower Parel, Mumbai–400 013, INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Revised : 01/2017 PT1819-03 FINASTERIDE TABLETS, USP Patient Information about FINASTERIDE TABLETS, USP Finasteride Tablets, USP is for use by men only. Please read this leaflet before you start taking Finasteride Tablets, USP. Also, read it each time you renew your prescription, just in case anything has changed.

Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss Finasteride Tablets, USP when you start taking your medication and at regular checkups. What are Finasteride Tablets, USP?

Finasteride Tablets, USP are a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Finasteride Tablets, USP may also be used to reduce the risk of the need for surgery related to BPH in men with an enlarged prostate. Finasteride Tablets, USP may be prescribed along with another medicine, an alpha-blocker called doxazosin, to help you better manage your BPH symptoms Who should NOT take Finasteride Tablets, USP?

Finasteride Tablets, USP are for use by MEN only. Do Not Take Finasteride Tablets, USP if you are: •a woman who is pregnant or may potentially be pregnant. Finasteride Tablets, USP may harm your unborn baby.

Do not touch or handle crushed or broken Finasteride Tablets, USP (see "A warning about Finasteride Tablets, USP and pregnancy" ). •allergic to finasteride or any of the ingredients in Finasteride Tablets, USP . See the end of this leaflet for a compl…

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