Home › NDC Lookup › Ingredients › Bicalutamide › 47335-0485-08
bicalutamide 50 mg Tablet, Film Coated, 100-count — NDC 47335-0485-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

bicalutamide 50 mg Tablet, Film Coated, 100-count — NDC 47335-485-08 (Billing 47335-0485-08)

by Sun Pharmaceutical Industries, Inc. · 100 TABLET, FILM COATED in 1 BOTTLE

This is a package of 100 tablets of bicalutamide 50 mg Tablet, Film Coated from Sun Pharmaceutical Industries, Inc., marketed since Dec 2014 and currently FDA-listed.

NDC 47335-0485-08
🏷️ FDA NDC (as labeled) 47335-485-08 billing pads the product segment with a zero
This package
Contains100-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.6045/unit — full pricing hub ↓
Product page 47335-0485-83 Also comes in: 30 tablets 47335-485-83 100 tablets 47335-485-88 1000 tablets 47335-485-18
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 47335-485-08
Product NDC 47335-485
11-digit billing NDC 47335048508
RxCUI 199123
UNII A0Z3NAU9DP
Application # ANDA079110
SPL Set ID 8b533fe4-287f-482c-b530-d9a5bf2ce40c
Established class (EPC) Androgen Receptor Inhibitor
Mechanism of action Androgen Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-12-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance BICALUTAMIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 21402420000320
GPI class Bicalutamide
GCN Seq No 024153
GCN 00450
HICL code 010143
Ingredient (HICL) Bicalutamide
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1J
Therapeutic class — specific (HIC3) Antineoplastic - Antiandrogenic Agents
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name BICALUTAMIDE 50 MG TABLET
FDB brand name Bicalutamide
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 024153
  • GCN: 00450
  • GPI-14 (Medi-Span): 21402420000320
  • HICL (First Databank): 010143
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 199123
Why two NDCs? The FDA registers this code as 47335-485-08 — 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 → 47335-0485-08. 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 Androgen Receptor Inhibitor class.

Pharmacologic class Androgen Receptor Inhibitor
Drug family (ATC) Anti-androgens
How it works Androgen Receptor 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.

Clinical

Label name BICALUTAMIDE 50 MG TABLET Ingredient Bicalutamide
📖 What it is MedlinePlus · NLM

Bicalutamide is used with another medication (gonadotropin-releasing hormone (GnRH) agonists; such as leuprolide or goserelin) to treat metastatic prostate cancer (cancer that started in the prostate and has spread to other parts of the body). Bicalutamide is in a class of medications called nonsteroidal antiandrogens. It works by blocking the effect of androgen (a male hormone), to stop the growth and spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's used along with an LHRH analog, another hormone therapy, to treat prostate cancer that has spread (Stage D2 metastatic). It blocks male hormones from fueling the cancer. It is...
  • Take one tablet by mouth once a day, morning or evening, with or without food. Try to take it at the same time each day and start it with your LHRH analog. If you miss a dose, just...
  • Hot flashes are the most common. Some people also have pain, tiredness, constipation, nausea, diarrhea, swelling, or blood in the urine. Tell your doctor if any of these bother you...
  • Bicalutamide can rarely cause serious liver injury, usually in the first few months. Testing before you start, regularly for four months, and then periodically helps catch problems...
📖 Read our full Bicalutamide 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.

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 $0.6045 $60.45 / 100 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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
47335-0485-08 You're viewing this 100 TABLET, FILM COATED in 1 BOTTLE — — 2014-12-15 — Active
47335-0485-18 47335-485-18 1000 TABLET, FILM COATED in 1 BOTTLE — — 2014-12-15 — Active
47335-0485-83 47335-485-83 Main listing 30 TABLET, FILM COATED in 1 BOTTLE $0.4044 / ea $12.13 2014-12-15 — Active
47335-0485-88 47335-485-88 100 TABLET, FILM COATED in 1 BOTTLE $0.4044 / ea $40.44 2014-12-15 — Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet, film coated in 1 bottle.
How does this package differ from NDC 47335-0485-83?
Both are bicalutamide 50 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 100-count one, while NDC 47335-0485-83 is the 30 tablets package.
What NDC number is used to bill for this package of bicalutamide 50 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bicalutamide 50 mg 62559-0890-30 ANI 30 tablets $0.289 AB FDA listed —
Bicalutamide 50 mg 16729-0023-01 Accord 100 tablets $0.404 AB Availability likely —
bicalutamide 50 mgthis 47335-0485-08 Sun 100 tablets — AB FDA listed —
Bicalutamide 50 mg 51407-0010-30 Golden 30 tablets — AB FDA listed —
Bicalutamide 50 mg 60429-0177-01 Golden 100 tablets — AB Discontinued —
Casodex 50 mg 62559-0680-30 ANI 30 tablets — AB FDA listed —
Bicalutamide 50 mg 63629-8308-01 Bryant 30 tablets — AB FDA listed —
Bicalutamide 50 mg 71205-0577-30 Proficient 30 tablets — AB FDA listed —
Bicalutamide 50 mg 72578-0215-01 Viona 100 tablets — AB FDA listed —
bicalutamide 50 mg 82804-0082-90 Proficient 90 tablets — AB FDA listed —
Bicalutamide 50 mg 84508-0001-01 PINNACLE 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

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color White
ShapeRound
Imprint485
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 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 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 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.

7 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.

Manufacturer & labeler

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA079110 (ANDA)
Labeler code47335
First marketedDec 2014
Product typeHuman Prescription Drug
Portfolio890 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 107 words ▾

1 INDICATIONS AND USAGE Bicalutamide tablets, USP 50 mg daily are indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. Bicalutamide tablets, USP 150 mg daily are not approved for use alone or with other treatments [see Clinical Studies (14.2)]. Bicalutamide tablet 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate.

(1) Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments. (1)

⏱️ Dosage and Administration 204 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dose for bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening). (2)

2.1Recommended Dose and Schedule The recommended dose for bicalutamide tablets therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide tablets be taken at the same time each day. Treatment with bicalutamide tablets should be started at the same time as treatment with an LHRH analog.

If a dose of bicalutamide tablets is missed, take the next dose at the scheduled time. Do not take the missed dose and do not double the next dose.

2.2Dosage Adjustment in Renal Impairment No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)].

2.3Dosage Adjustment in Hepatic Impairment No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide, no dosage adjustment is necessary [see Use in Specific Populations (8.6)].

💊 Dosage Forms and Strengths 16 words ▾

3 DOSAGE FORMS AND STRENGTHS Bicalutamide 50 mg tablets for oral administration. 50 mg tablets (3)

⛔ Contraindications 84 words ▾

4 CONTRAINDICATIONS Bicalutamide is contraindicated in: Hypersensitivity Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported. Women Bicalutamide has no indication for women, and should not be used in this population.

Pregnancy Bicalutamide can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)]. Hypersensitivity ( 4 ) Women ( 4 ) Pregnancy ( 4, 8.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Severe hepatic injury and fatal hepatic failure have been observed. Monitor serum transaminase levels prior to starting treatment with bicalutamide, at regular intervals for the first four months of treatment and periodically thereafter, and for symptoms or signs suggestive of hepatic dysfunction. Use bicalutamide with caution in patients with hepatic impairment.

( 5.1 ) Hemorrhage with Concomitant Use of Coumarin Anticoagulant. Closely monitor the Prothrombin Time (PT) and International Normalized Ratio (INR), and adjust the anticoagulant dose as needed. ( 5.2 ) Gynecomastia and breast pain have been reported during treatment with bicalutamide 150 mg when used as a single agent.

( 5.3 ) Bicalutamide is used in combination with an LHRH agonist. LHRH agonists have been shown to cause a reduction in glucose tolerance in males. Consideration should be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists.

( 5.4 ) Monitoring Prostate Specific Antigen (PSA) is recommended. Evaluate for clinical progression if PSA increases. ( 5.5 )

5.1Hepatitis Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of bicalutamide. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of bicalutamide patients in controlled clinical trials.

Serum transaminase levels should be measured prior to starting treatment with bicalutamide, at regular intervals for the first four months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, “flu-like” symptoms, dark urine, jaundice, or right upper quadrant tenderness), the serum transaminases, in particular the serum ALT, should be measured immediately. If at any time a patient has jaundice, or their ALT rises above two times the upper limit of normal, bicalutamide should be immediately discontinued with close follow-up of liver function.

5.2Hemorrhage with Concomitant Use of Coumarin Anticoagulant In the postmarketing setting, there have been reports of excessive prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) days to weeks after the introduction of bicalutamide in patients who were previously stable on coumarin anticoagulants. Some patients had serious bleeding including intracranial, retroperitoneal, and gastrointestinal requiring blood transfusion and/or administration of vitamin K. Closely monitor the PT/INR, and adjust the anticoagulant dose as needed [see Drug Interactions (7) and Adverse Reactions (6.2)].

5.3Gynecomastia and Breast Pain In clinical trials with bicalutamide 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively.

5.4Glucose Tolerance A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycemic control in those with preexisting diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists.

5.5Laboratory Tests Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient’s response. If PSA levels rise during bicalutamide therapy, the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment-free period of antiandrogen, while continuing the LHRH analog, may be considered.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions that occurred in more than 10% of patients receiving bicalutamide plus an LHRH-A were: hot flashes, pain (including general, back, pelvic and abdominal), asthenia, constipation, infection, nausea, peripheral edema, dyspnea, diarrhea, hematuria, nocturia, and anemia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience In patients with advanced prostate cancer treated with bicalutamide in combination with an LHRH analog, the most frequent adverse reaction was hot flashes (53%). In the multi-center, double-blind, controlled clinical trial comparing bicalutamide 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analog, the following adverse reactions with an incidence of 5% or greater, regardless of causality, have been reported. Table 1 Incidence of Adverse Reactions (≥ 5% in Either Treatment Group) Regardless of Causality Body System Adverse Reaction Treatment Group Number of Patients (%) Bicalutamide Plus LHRH Analog (n=401) Flutamide Plus LHRH Analog (n=407) Body as a Whole Pain (General) 142 (35) 127 (31) Back Pain 102 (25) 105 (26) Asthenia 89 (22) 87 (21) Pelvic Pain 85 (21) 70 (17) Infection 71 (18) 57 (14) Abdominal Pain 46 (11) 46 (11) Chest Pain 34 (8) 34 (8) Headache 29 (7) 27 (7) Flu Syndrome 28 (7) 30 (7) Cardiovascular Hot Flashes 211 (53) 217 (53) Hypertension 34 (8) 29 (7) Digestive Constipation 87 (22) 69 (17) Nausea 62 (15) 58 (14) Diarrhea 49 (12) 107 (26) Increased Liver Enzyme Test 30 (7) 46 (11) Dyspepsia 30 (7) 23 (6) Flatulence 26 (6) 22 (5) Anorexia 25 (6) 29 (7) Vomiting 24 (6) 32 (8) Hemic and Lymphatic Anemia 45 (11) 53 (13) Metabolic and Nutritional Peripheral Edema 53 (13) 42 (10) Weight Loss 30 (7) 39 (10) Hyperglycemia 26 (6) 27 (7) Alkaline Phosphatase Increased 22 (5) 24 (6) Weight Gain 22 (5) 18 (4) Musculoskeletal Bone Pain 37 (9) 43 (11) Myasthenia 27 (7) 19 (5) Arthritis 21 (5) 29 (7) Pathological Fracture 17 (4) 32 (8) Nervous System Dizziness 41 (10) 35 (9) Paresthesia 31 (8) 40 (10) Insomnia 27 (7) 39 (10) Anxiety 20 (5) 9 (2) Depression 16 (4) 33 (8) Respiratory System Dyspnea 51 (13) 32 (8) Cough Increased 33 (8) 24 (6) Pharyngitis 32 (8) 23 (6) Bronchitis 24 (6) 22 (3) Pneumonia 18 (4) 19 (5) Rhinitis 15 (4) 22 (5) Skin and Appendages Rash 35 (9) 30 (7) Sweating 25 (6) 20 (5) Urogenital Nocturia 49 (12) 55 (14) Hematuria 48 (12) 26 (6) Urinary Tract Infection 35 (9) 36 (9) Gynecomastia 36 (9) 30 (7) Impotence 27 (7) 35 (9) Breast Pain 23 (6) 15 (4) Urinary Frequency 23 (6) 29 (7) Urinary Retention 20 (5) 14 (3) Urinary Impaired 19 (5) 15 (4) Urinary Incontinence 15 (4) 32 (8) Other adverse reactions (greater than or equal to 2%, but less than 5%) reported in the bicalutamide-LHRH analog treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality.

Body as a Whole: Neoplasm; Neck Pain; Fever; Chills; Sepsis; Hernia; Cyst Cardiovascular: Angina Pectoris; Congestive Heart Failure; Myocardial Infarct; Heart Arrest; Coronary Artery Disorder; Syncope Digestive: Melena; Rectal Hemorrhage; Dry Mouth; Dysphagia; Gastrointestinal Disorder; Periodontal Abscess; Gastrointestinal Carcinoma Metabolic and Nutritional: Edema; BUN Increased; Creatinine Increased; Dehydration; Gout; Hypercholesteremia Musculoskeletal: Myalgia; Leg Cramps Nervous: Hypertonia; Confusion; Somnolence; Libido Decreased; Neuropathy; Nervousness Respiratory: Lung Disorder; Asthma; Epistaxis; Sinusitis Skin and Appendages: Dry Skin; Alopecia; Pruritus; Herpes Zoster; Skin Carcinoma… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 176 words ▾

7 DRUG INTERACTIONS Clinical studies have not shown any drug interactions between bicalutamide and LHRH analogs (goserelin or leuprolide). There is no evidence that bicalutamide induces hepatic enzymes. In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity.

Clinical studies have shown that with coadministration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC). Hence, caution should be exercised when bicalutamide is coadministered with CYP 3A4 substrates. In vitro protein-binding studies have shown that bicalutamide can displace coumarin anticoagulants from binding sites.

PT/INR should be closely monitored in patients concomitantly receiving coumarin anticoagulants and bicalutamide. Adjustment of the anticoagulant dose may be necessary [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)]. R-bicalutamide is an inhibitor of CYP 3A4; therefore, caution should be used when bicalutamide is coadministered with CYP 3A4 substrates.

(7) PT/INR should be closely monitored in patients already receiving coumarin anticoagulants who are started on bicalutamide. (7)

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception. ( 8.3 ) Pediatric patients: Efficacy has not been demonstrated for the treatment of familial male-limited precocious puberty (testotoxicosis). ( 8.4 )

8.1Pregnancy Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of bicalutamide in pregnant women.

In animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose (see Data). Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, male fetuses had reduced anogenital distance at doses of 10 mg/kg/day and above (approximately 0.7 to 2 times the human exposure at the recommended dose).

In a pre- and post-natal development study, female rats were dosed from gestation day 7-16 and allowed to litter and rear their offspring to weaning. Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance. In a peri- and post-natal development study, female rats were dosed from gestation day 16 to lactation day 22 and allowed to litter and rear their offspring to weaning.

Survival and weights of offspring during lactation were reduced for litters from maternal rats receiving doses of 250 mg/kg/day (approximately 2 times the human exposure at the recommended dose). Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance, smaller secondary sex organs, cryptorchidism and hypospadias resulting in an inability to mate and impregnate their female partners. Female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above had reduced pregnancy rates.

8.2Lactation Risk Summary Bicalutamide is not indicated for use in pregnant women. There is no information available on the presence of bicalutamide in human milk, or on the effects on the breastfed infant or on milk production. Bicalutamide has been detected in rat milk.

8.3Females and Males of Reproductive Potential Contraception Males Antiandrogen therapy may cause morphological changes in spermatozoa [see Nonclinical Toxicology (13.1)]. Based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the final dose of bicalutamide [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1)]. Infertility Males Based on animal studies, bicalutamide can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential.

The long-term effects of bicalutamide on male fertility have not been studied [see Nonclinical Toxicology (13.1)] .

8.4Pediatric Use The safety and effectiveness of bicalutamide in pediatric patients have not been established. Bicalutamide orodispersible tablet was studied in combination with Arimidex # (anastrozole) orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis. Patients were enrolled in the study if they had a baseline age ≥2 years and a diagnosis of testotoxicosis based on clinical features of progre… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of bicalutamide in pregnant women.

In animal reproduction studies, oral administration of bicalutamide to pregnant rats during organogenesis caused abnormal development of reproductive organs in male fetuses at exposures approximately 0.7 to 2 times the human exposure at the recommended dose (see Data). Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, male fetuses had reduced anogenital distance at doses of 10 mg/kg/day and above (approximately 0.7 to 2 times the human exposure at the recommended dose).

In a pre- and post-natal development study, female rats were dosed from gestation day 7-16 and allowed to litter and rear their offspring to weaning. Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance. In a peri- and post-natal development study, female rats were dosed from gestation day 16 to lactation day 22 and allowed to litter and rear their offspring to weaning.

Survival and weights of offspring during lactation were reduced for litters from maternal rats receiving doses of 250 mg/kg/day (approximately 2 times the human exposure at the recommended dose). Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance, smaller secondary sex organs, cryptorchidism and hypospadias resulting in an inability to mate and impregnate their female partners. Female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above had reduced pregnancy rates.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of bicalutamide in pediatric patients have not been established. Bicalutamide orodispersible tablet was studied in combination with Arimidex # (anastrozole) orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis. Patients were enrolled in the study if they had a baseline age ≥2 years and a diagnosis of testotoxicosis based on clinical features of progressive precocious puberty, symmetrical testicular enlargement, advanced bone age, pubertal levels of serum testosterone, prepubertal pattern of gonadotropin secretion following a GnRH stimulation test, and absence of other clinical and biochemical causes of testosterone excess.

Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). If central precocious puberty (CPP) developed, an LHRH analog was to be added. Four patients were diagnosed with CPP during the 12-month study and received LHRH analog treatment and 2 additional patients were diagnosed at the end of the 12 months and received treatment subsequently.

Mean ± SD characteristics at baseline were as follows: chronological age: 3.9±1.9 years; bone age 8.8±2.5; bone age/chronological age ratio: 2.06±0.51; growth rate (cm/yr): 10.81±4.22; growth rate standard deviation score (SDS): 0.41±1.36. The starting bicalutamide dose was 12.5 mg. Bicalutamide was titrated in each patient until steady-state R-bicalutamide (the active isomer of bicalutamide) trough plasma concentration reached 5 mcg/mL to 15 mcg/mL, which is the range of therapeutic concentrations achieved in adults with prostate cancer following the administration of the currently approved bicalutamide dose of 50 mg.

The starting daily dose of anastrozole was 0.5 mg. Anastrozole was independently titrated in each patient until it reached at steady-state a serum estradiol concentration of <10 pmol/L (2.7 pg/mL). The following ascending doses were used for bicalutamide: 12.5 mg, 25 mg, 50 mg, and 100 mg.

For anastrozole there were two ascending doses: 0.5 mg and 1 mg. At the end of the titration phase, 1 patient was on 12.5 mg bicalutamide, 8 patients were on 50 mg bicalutamide, and 4 patients were on 100 mg bicalutamide; 10 patients were on 0.5 mg anastrozole and 3 patients were on 1 mg anastrozole. In the majority of patients, steady-state trough concentrations of R-bicalutamide appeared to be attained by Day 21 with once daily dosing.

Steady-state trough plasma anastrozole concentrations appeared to be attained by Day 8. The primary efficacy analysis of the study was to assess the change in growth rate after 12 months of treatment, relative to the growth rate during the ≥6 months prior to entering the study. Pre-study growth rates were obtained retrospectively.

There was no statistical evidence that the growth rate was reduced during treatment. During bicalutamide / Arimidex # treatment the mean growth rate (cm/yr) decreased by 1.6 cm/year, 95% CI (-4.7 to 1.5) p=0.28; the mean growth rate SDS decreased by

0.1SD, 95% CI (–1.2 to 1.0) p=0.88. Table 2 shows descriptive data for growth rates for the overall population and for subgroups defined by history of previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. Table 2.

Growth Rates Endpoint Analysis Population Pre-study Mean Change from pre-study to 12 months % patients with growth reduction Change compared to pre-study growth rate. Mean Median (Min, Max) Growth rate (cm/yr) All treated (n=13) 10.8 -1.6 -2.8 (-7.4, 8.4) 9/13 (69%) PT PT = Previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors. (n=6) 10.3 -0.2 -2.6 Median calculated as midpoint o… [Excerpted — this section continues on DailyMed.]

🧓 Geriatric Use 33 words ▾

8.5Geriatric Use In two studies in patients given 50 mg or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.

🆘 Overdosage 123 words ▾

10 OVERDOSAGE Long-term clinical trials have been conducted with dosages up to 200 mg of bicalutamide daily and these dosages have been well tolerated. A single dose of bicalutamide that results in symptoms of an overdose considered to be life threatening has not been established. There is no specific antidote; treatment of an overdose should be symptomatic.

In the management of an overdose with bicalutamide, vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since bicalutamide is highly protein bound and is extensively metabolized.

General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.

When bicalutamide is combined with LHRH analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted. In a subset of patients who have been treated with bicalutamide and an LHRH agonist, and who discontinue bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.

12.3Pharmacokinetics Absorption Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Coadministration of bicalutamide with food has no clinically significant effect on rate or extent of absorption. Distribution Bicalutamide is highly protein-bound (96%) [see Drug Interactions (7)].

Metabolism/Elimination Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation.

Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels. Pharmacokinetics of the active enantiomer of bicalutamide in normal males and patients with prostate cancer are presented in Table 3.

Table 3. Pharmacokinetics of Bicalutamide Active Enantiomer Parameter Mean Standard Deviation Normal Males (n=30) Apparent Oral Clearance (L/hr) 0.320 0.103 Single Dose Peak Concentration (mcg/mL) 0.768 0.178 Single Dose Time to Peak Concentration (hours) 31.3

14.6Half-life (days) 5.8

2.29Patients with Prostate Cancer (n=40) C ss (mcg/mL) 8.939 3.504

🧬 Mechanism of Action 137 words ▾

12.1Mechanism of Action Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.

When bicalutamide is combined with LHRH analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with bicalutamide as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted. In a subset of patients who have been treated with bicalutamide and an LHRH agonist, and who discontinue bicalutamide therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.

📦 How Supplied / Storage and Handling 75 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING White to off white, circular, biconvex, film-coated tablets debossed with “485” on one side and plain on other side. Bottles of 30 with Child Resistant Cap……….…..…. NDC 47335-485-83 Bottles of 100 with Child Resistant Cap………….…..NDC 47335-485-88 Bottles of 100…..…….…..…….…..…….…..…….…..…….NDC 47335-485-08 Bottles of 1000…..…….…..…….…..…….…..…….……….NDC 47335-485-18

16.1Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

📋 Description 132 words ▾

11 DESCRIPTION Bicalutamide tablets contain 50 mg of bicalutamide USP, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and molecular formulas are: Bicalutamide has a molecular weight of 430.37.

The pKa is approximately 12. Bicalutamide is a fine white to off-white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran. Bicalutamide tablet is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive.

The inactive ingredients of bicalutamide tablets are lactose monohydrate, sodium starch glycolate type A, povidone, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. bicalutamide-structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dose and Schedule: Inform patients that therapy with bicalutamide and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their healthcare provider [see Dosage and Administration (2.1)]. Hepatitis: Inform patients that bicalutamide can cause hepatitis, which may result in hepatic failure and death.

Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis [see Warnings and Precautions (5.1)]. Hemorrhage with Concomitant Use of Coumarin Anticoagulant: Inform patients that serious bleeding has occurred with reported increased anticoagulant effects while taking bicalutamide. Advise patients to notify their healthcare provider of any bleeding or spontaneous bruising while on bicalutamide and taking anticoagulants [see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].

Glucose Tolerance: Inform patients that diabetes or loss of glycemic control in patients with preexisting diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists [see Warnings and Precautions (5.4)]. Somnolence: During treatment with bicalutamide, somnolence has been reported.

Advise patients who experience this symptom to observe caution when driving or operating machines [see Adverse Reactions (6.1)]. Photosensitivity: Inform patients that cases of photosensitivity have been reported during treatment with bicalutamide and that they should avoid direct exposure to excessive sunlight or UV-light exposure. Consideration should be given to the use of sunscreen [see Adverse Reactions (6.2)].

Contraception and fertility: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the last dose of bicalutamide therapy. Advise male patients that bicalutamide may impair fertility [see Use in Specific Populations (8.3)]. Dispense with Patient Information available at: https://www.sunpharma.com/usa/products

🍼 Nursing Mothers 107 words ▾

8.3Females and Males of Reproductive Potential Contraception Males Antiandrogen therapy may cause morphological changes in spermatozoa [see Nonclinical Toxicology (13.1)]. Based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the final dose of bicalutamide [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1)]. Infertility Males Based on animal studies, bicalutamide can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential.

The long-term effects of bicalutamide on male fertility have not been studied [see Nonclinical Toxicology (13.1)] .

🧬 Pharmacokinetics 177 words ▾

12.3Pharmacokinetics Absorption Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Coadministration of bicalutamide with food has no clinically significant effect on rate or extent of absorption. Distribution Bicalutamide is highly protein-bound (96%) [see Drug Interactions (7)].

Metabolism/Elimination Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation.

Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels. Pharmacokinetics of the active enantiomer of bicalutamide in normal males and patients with prostate cancer are presented in Table 3.

Table 3. Pharmacokinetics of Bicalutamide Active Enantiomer Parameter Mean Standard Deviation Normal Males (n=30) Apparent Oral Clearance (L/hr) 0.320 0.103 Single Dose Peak Concentration (mcg/mL) 0.768 0.178 Single Dose Time to Peak Concentration (hours) 31.3

14.6Half-life (days) 5.8

2.29Patients with Prostate Cancer (n=40) C ss (mcg/mL) 8.939 3.504

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Bicalutamide 50 mg Daily in Combination with an LHRH-A In a multi-center, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive bicalutamide 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with LHRH analogs (either goserelin acetate implant or leuprolide acetate depot). In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with bicalutamide-LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died.

There was no significant difference in survival between treatment groups (see Figure 1). The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05). There was no significant difference in time to objective tumor progression between treatment groups (see Figure 2).

Objective tumor progression was defined as the appearance of any bone metastases or the worsening of any existing bone metastases on bone scan attributable to metastatic disease, or an increase by 25% or more of any existing measurable extraskeletal metastases. The hazard ratio for time to progression of bicalutamide plus LHRH analog to that of flutamide plus LHRH analog was 0.93 (95% confidence interval, 0.79 to 1.10). Quality of life was assessed with self-administered patient questionnaires on pain, social functioning, emotional well being, vitality, activity limitation, bed disability, overall health, physical capacity, general symptoms, and treatment related symptoms.

Assessment of the Quality of Life questionnaires did not indicate consistent significant differences between the two treatment groups. bicalutamide-figure-1 bicalutamide-figure-2

14.2Safety Data from Clinical Studies using Bicalutamide 150 mg Bicalutamide 150 mg is not approved for use either alone or with other treatments. Two identical multi-center, randomized, open-label trials comparing bicalutamide 150 mg daily monotherapy to castration were conducted in patients that had locally advanced (T3-4, NX, M0) or metastatic (M1) prostate cancer. Monotherapy — M1 Group Bicalutamide 150 mg daily is not approved for use in patients with M1 cancer of the prostate.

Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that bicalutamide treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the bicalutamide treated group compared to that in the castrated group, respectively. Locally Advanced (T3-4, NX, M0) Group Bicalutamide 150 mg daily is not approved for use in patients with locally advanced (T3-4, NX, M0) cancer of the prostate.

Following discontinuation of all M1 patients, the trials continued with the T3-4, NX, M0 patients until study completion. In the larger trial (N=352), the risk of death was 25% (HR 1.25, 95% CI 0.92 to 1.71) higher in the bicalutamide group and in the smaller trial (N=140), the risk of death was 36% (HR 0.64, 95% CI, 0.39 to 1.03) lower in the bicalutamide group. In addition to the above two studies, there are three other ongoing clinical studies that provide additional safety information for bicalutamide 150 mg, a dose that is not approved for use.

These are three multi-center, randomized, double-blind, parallel group trials comparing bicalutamide 150 mg daily monotherapy (adjuvant to previous therapy or under watchful waiting) with placebo, for death or time to disease progression, in a population of 8113 patients with localized or locally advanced prostate cancer. Bicalutamide 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Data from a planned subgroup analysis of two of these trials in 1627 patients with localized prostate cancer who were under watchful waiting,… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 5, 15, or 75 mg/kg/day of bicalutamide. A variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of bicalutamide, namely, testicular benign interstitial (Leydig) cell tumors in male rats at all dose levels (the steady-state plasma concentration with the 5 mg/kg/day dose is approximately 0.7 times the human exposure at the recommended dose) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1.5 times the human exposure at the recommended dose).

There is no evidence of Leydig cell hyperplasia in patients; uterine tumors are not relevant to the indicated patient population. A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of bicalutamide (approximately 4 times the human exposure at the recommended dose) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies.

Enzyme induction has not been observed following bicalutamide administration in man. There were no tumorigenic effects suggestive of genotoxic carcinogenesis. A comprehensive battery of both in vitro and in vivo genotoxicity tests (yeast gene conversion, Ames, E. coli , CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that bicalutamide does not have genotoxic activity.

In repeat-dose toxicology studies, atrophy of seminiferous tubules of the testes has been observed for all species examined, which is a predicted class effect with antiandrogens. In the 6- and 12-month rat study, testicular atrophy was seen at approximately 2 times the human exposure at the recommended dose. In the 12-month dog study, the incidence of testicular atrophy was seen at approximately 7 times the human exposure at the recommended dose.

In male rats administered 250 mg/kg/day (approximately 2 times human exposure at the recommended dose), the precoital interval and time to successful mating were increased in the first pairing, but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11-week period of dosing. Female rats dosed at 1, 10 and 250 mg/kg/day (less than to 2 times the human exposure at the recommended dose) had increased estrous cycle irregularity but there was no effect on fertility.

In a peri- and post-natal development study, female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended clinical dose) and above had reduced pregnancy rates. Administration of bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above. Affected male offspring were also impotent.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 5, 15, or 75 mg/kg/day of bicalutamide. A variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of bicalutamide, namely, testicular benign interstitial (Leydig) cell tumors in male rats at all dose levels (the steady-state plasma concentration with the 5 mg/kg/day dose is approximately 0.7 times the human exposure at the recommended dose) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1.5 times the human exposure at the recommended dose).

There is no evidence of Leydig cell hyperplasia in patients; uterine tumors are not relevant to the indicated patient population. A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of bicalutamide (approximately 4 times the human exposure at the recommended dose) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies.

Enzyme induction has not been observed following bicalutamide administration in man. There were no tumorigenic effects suggestive of genotoxic carcinogenesis. A comprehensive battery of both in vitro and in vivo genotoxicity tests (yeast gene conversion, Ames, E. coli , CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that bicalutamide does not have genotoxic activity.

In repeat-dose toxicology studies, atrophy of seminiferous tubules of the testes has been observed for all species examined, which is a predicted class effect with antiandrogens. In the 6- and 12-month rat study, testicular atrophy was seen at approximately 2 times the human exposure at the recommended dose. In the 12-month dog study, the incidence of testicular atrophy was seen at approximately 7 times the human exposure at the recommended dose.

In male rats administered 250 mg/kg/day (approximately 2 times human exposure at the recommended dose), the precoital interval and time to successful mating were increased in the first pairing, but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11-week period of dosing. Female rats dosed at 1, 10 and 250 mg/kg/day (less than to 2 times the human exposure at the recommended dose) had increased estrous cycle irregularity but there was no effect on fertility.

In a peri- and post-natal development study, female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended clinical dose) and above had reduced pregnancy rates. Administration of bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above. Affected male offspring were also impotent.

📄 Patient Package Insert ~3 min read ▾

Patient Information Bicalutamide (BYE-ka-LOO-ta-mide) Tablets, USP What are bicalutamide tablets? Bicalutamide tablets are prescription medicines called androgen receptor inhibitors, used in combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat Stage D 2 metastatic prostate cancer. Bicalutamide tablet 150 mg daily is not approved for use alone or with other treatments.

It is not known if bicalutamidetablets are safe and effective in children. Do not take bicalutamide tablets if you are: allergic to bicalutamide or any of the ingredients in bicalutamide tablets. See the end of this Patient Information leaflet for a complete list of ingredients in bicalutamide tablets.

Get medical help right away if you develop any of the following symptoms of an allergic reaction: itching hives (raised bumps) swelling of the face, lips or tongue trouble breathing or swallowing female. Bicalutamide tablets are not for use by women. pregnant or may become pregnant. Bicalutamide may harm your unborn baby.

Before taking bicalutamide tablets, tell your healthcare provider about all your medical conditions, including if you: have liver problems. take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner. have diabetes. have a female partner who can become pregnant. Males who have a female partner who can become pregnant should use effective birth control during treatment with bicalutamide tablets and for 130 days after the final dose.

Talk to your healthcare provider if you have any questions about birth control. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bicalutamide tablets may affect the way other medicines work and other medicines may affect how bicalutamide tablets work, causing side effects.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine. How should I take bicalutamide tablets?

Take bicalutamide tablets exactly as your healthcare provider tells you to take it. Do not stop taking bicalutamide tablets unless your healthcare provider tells you to. Bicalutamide tablets can be taken either in the morning or in the evening, but you should take it at the same time every day.

Your treatment with bicalutamide tablets should start at the same time as your treatment with the LHRH medicine. If you miss a bicalutamide tablets dose do not take the missed dose, take the next dose at your next scheduled time. Do not take 2 doses at the same time.

Bicalutamide tablets can be taken with or without food. If you take too much bicalutamide tablets, call your healthcare provider or go to the nearest hospital emergency room right away. What should I avoid during treatment with bicalutamide tablets?

Do not drive, operate machinery, or do other dangerous activities until you know how bicalutamide tablets affect you. Bicalutamide tablets can make you sleepy. Avoid sunlight, sunlamps, and tanning beds, and consider using sunscreen during treatment with bicalutamide tablets.

Some people have had skin sensitivity to sunlight during treatment with bicalutamide tablets. What are the possible side effects of bicalutamide tablets? Bicalutamide tablets may cause serious side effects, including: Liver problems.

Severe liver problems, including liver failure that may need to be treated in a hospital or that may lead to death have happened in people who take bicalutamide tablets. Your healthcare provider should do blood tests to check your liver function before and during treatment with bicalutamide tablets. Tell your healthcare provider right away if you develop any of these symptoms of liver problems during treatment: yellowing of the skin and eyes (jaundice) dark urine right upper stomach pain nausea vomiting tiredness loss of appetite chills fever Bleeding problems.

Serious bleeding pro… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 19 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 47335-485-83 Bicalutamide Tablets, USP 50 mg Rx only 30 Tablets SUN PHARMA spl-bicalutamide tablet-label

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

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.
30 tablets47335-0485-83 9,228 Rx · $205,841
100 tablets47335-0485-88 3,591 Rx · $77,548
100 tablets this page47335-0485-08 No Medicaid data
1000 tablets47335-0485-18 No Medicaid data
Drug total (last 4 qtrs): 12,819 Rx · 473,504 units · $283,389 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Bicalutamide — the program that covers self-administered drugs. 4 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 Bicalutamide. 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
$1.79M
Claims incl. refills
46.6K
Beneficiaries
31.8K
Spend / beneficiary
$56.30
Spend / claim
$38.44
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 30 tablets (47335-0485-83), 100 tablets (47335-0485-88), 1000 tablets (47335-0485-18). 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?
Sun Pharmaceutical Industries, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 47335-0475-13 · Sun 47335-0506-96 · Sun →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.