Home › NDC Lookup › Ingredients › Anastrozole › 72189-0682-30
Anastrozole 1 mg Tablet, 30-count — NDC 72189-0682-30 package photo

Anastrozole 1 mg Tablet, 30-count

by Direct_Rx · 30 TABLET in 1 BOTTLE (72189-682-30)
NDC 72189-0682-30
🏷️ FDA NDC (as labeled) 72189-682-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Aug 20, 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) 72189-682-30
Product NDC 72189-682
11-digit billing NDC 72189068230
RxCUI 199224
UNII 2Z07MYW1AZ
Application # ANDA206037
SPL Set ID 58390d1f-7390-a21f-e063-6294a90a0479
Established class (EPC) Aromatase Inhibitor
Mechanism of action Aromatase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-03
Route ORAL
Dosage form TABLET
Substance ANASTROZOLE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-682-30 — 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 → 72189-0682-30. 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 Aromatase Inhibitor class.

Pharmacologic class Aromatase Inhibitor
Drug family (ATC) Aromatase inhibitors
How it works Aromatase 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

LabelerDirect_Rx
Application holderBEIJING YILING BIO-ENGINEERING TECHNOLOGY CO LTD
FDA applicationANDA206037 (ANDA)
Labeler code72189
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio352 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

📖 What it is MedlinePlus · NLM

Anastrozole is used with other treatments, such as surgery or radiation, to treat early breast cancer in women who have experienced menopause (change of life; end of monthly menstrual periods). This medication is also used in women, who have experienced menopause, as a first treatment of breast cancer that has spread within the breast or to other areas of the body. This medication is also used to treat breast cancer in women whose breast cancer has worsened after taking tamoxifen (Nolvadex). Anastrozole is in a class of medications called nonsteroidal aromatase inhibitors. It works by decreasi...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Great question. After menopause, your body still makes small amounts of estrogen through an enzyme called aromatase — and many breast cancers use that estrogen as fuel to grow. Ana...
  • What exactly is anastrozole doing in my body to fight breast cancer?
  • You can take it either way — with or without food. Food does slow down how quickly your body absorbs it, but the total amount that gets into your system stays the same. Pick whatev...
  • Can I take anastrozole with food, or does it have to be on an empty stomach?
📖 Read our full Anastrozole 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 white
ShapeRound
ImprintYL;111
Size6 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 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.

8 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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
Anastrozole 1 mg 00093-7536-56 Teva 30 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 51991-0620-10 Breckenridge 1000 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 68001-0155-04 BluePoint 30 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 60687-0112-21 American 1 tablet $0.140 AB Availability likely —
Anastrozole 1 mg 16729-0035-10 Accord 30 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 68382-0209-06 Zydus 30 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 59651-0236-30 Aurobindo 30 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 50268-0075-15 AvPAK 50 tablets $0.140 AB Availability likely —
Anastrozole 1 mg 62135-0490-30 Chartwell 30 tablets $0.140 AB Availability likely —
Arimidex 1 mg 62559-0670-30 ANI 30 tablets $52.862 AB Availability likely —
Anastrozole 1 mg 63850-0010-01 Natco 30 tablets — AB FDA listed —
Anastrozole 1 mg 63187-0080-18 Proficient 18 tablets — AB FDA listed —
Anastrozole 1 mg 63629-5269-00 Bryant 28 tablets — AB FDA listed —
Anastrozole 1 mg 68071-1682-03 NuCare 30 tablets — AB FDA listed —
Anastrozole 1 mg 68071-1543-09 NuCare 90 tablets — AB FDA listed —
Anastrozole 1 mg 68071-4038-03 NuCare 30 tablets — AB FDA listed —
Anastrozole 1 mg 71335-1879-00 Bryant 28 tablets — AB FDA listed —
Anastrozole 1 mg 68071-3838-09 NuCare 90 tablets — AB FDA listed —
Anastrozole 1 mg 68071-3853-07 NuCare 12 tablets — AB FDA listed —
Anastrozole 1 mg 72789-0342-15 PD-Rx 15 tablets — AB FDA listed —
Anastrozole 1 mg 50090-2453-00 A-S 30 tablets — AB FDA listed —
Anastrozole 1 mg 43063-0383-06 PD-Rx 6 tablets — AB FDA listed —
Anastrozole 1 mg 71335-3145-00 Bryant 28 tablets — AB FDA listed —
Anastrozole 1 mg 72789-0008-15 PD-Rx 15 tablets — AB FDA listed —
Anastrozole 1 mg 68071-2791-05 NuCare 15 tablets — AB FDA listed —
Anastrozole 1 mg 65841-0743-06 Zydus 30 tablets — AB FDA listed —
Anastrozole 1 mg 50090-5002-00 A-S 30 tablets — AB FDA listed —
Anastrozole 1 mg 72189-0415-30 Direct_Rx 30 tablets — AB FDA listed —
Anastrozole 1 mg 76420-0004-12 Asclemed 120 tablets — AB FDA listed —
Anastrozole 1 mg 42291-0016-30 AvKARE 30 tablets — AB FDA listed —
Anastrozole 1 mg 42291-0085-30 AvKARE 30 tablets — AB FDA listed —
Anastrozole 1 mg 68071-5203-03 NuCare 30 tablets — AB FDA listed —
Anastrozole 1 mg 72789-0575-15 PD-Rx 15 tablets — AB FDA listed —
Anastrozole 1 mgthis 72189-0682-30 Direct_Rx 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

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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 Anastrozole — the program that covers self-administered drugs. 9 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 Anastrozole. 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
$8.82M
Claims incl. refills
434.6K
Beneficiaries
334.3K
Spend / beneficiary
$26.38
Spend / claim
$20.30
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
72189-0682-30 You're viewing this 30 TABLET in 1 BOTTLE (72189-682-30) 2026-08-03 Active

🧭 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 72189-682-30, 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: 72189-0682-30, written without dashes as 72189068230. 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 72189-0682-30, the first segment (72189) is the labeler code FDA assigned to Direct_Rx; the middle segment (0682) 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 Direct_Rx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Direct_Rx 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 84 words ▾

1.1Adjuvant Treatment Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

1.2First-Line Treatment Anastrozole is indicated for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.

1.3Second-Line Treatment Anastrozole is indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole.

⏱️ Dosage and Administration 124 words ▾

2.1Recommended Dose The dose of anastrozole is one 1 mg tablet taken once a day. For patients with advanced breast cancer, anastrozole tablets should be continued until tumor progression.Anastrozole tablets can be taken with or without food. For adjuvant treatment of early breast cancer in postmenopausal women, the optimal duration of therapy is unknown.

In the ATAC trial, anastrozole was administered for five years [see Clinical Studies (14.1)]. No dosage adjustment is necessary for patients with renal impairment or for elderly patients [see Use in Specific Populations (8.6)].

2.2Patients with Hepatic Impairment No changes in dose are recommended for patients with mild-to-moderate hepatic impairment. Anastrozole tablets have not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

💊 Dosage Forms and Strengths 22 words ▾

Anastrozole Tablets, USP 1 mg are white, circular, biconvex tablets, debossed with ‘YL’ on one side, and ‘111’ on the other side.

⛔ Contraindications 33 words ▾

Hypersensitivity Anastrozole is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients. Observed reactions include anaphylaxis, angioedema, and urticaria [see Adverse Reactions (6.2)].

⚠️ Warnings and Cautions ~1 min read ▾

5.1Ischemic Cardiovascular Events In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events was observed with anastrozole in the ATAC trial (17% of patients on anastrozole and 10% of patients on tamoxifen). Consider risk and benefits of anastrozole therapy in patients with pre-existing ischemic heart disease [see Adverse Reactions (6.1)].

5.2Bone Effects Results from the ATAC trial bone substudy at 12 and 24 months demonstrated that patients receiving anastrozole had a mean decrease in both lumbar spine and total hip bone mineral density (BMD) compared to baseline. Patients receiving tamoxifen had a mean increase in both lumbar spine and total hip BMD compared to baseline. Consider bone mineral density monitoring in patients treated with anastrozole tablets[see Adverse Reactions (6.1)].

5.3Cholesterol During the ATAC trial, more patients receiving anastrozole were reported to have elevated serum cholesterol compared to patients receiving tamoxifen (9% versus 3.5%, respectively) [see Adverse Reactions (6.1)].

5.4Embryo-Fetal Toxicity Based on findings from animal studies and its mechanism of action, anastrozole can cause fetal harm when administered to a pregnant woman. Anastrozole caused embryo-fetal toxicities in rats at maternal exposure that were 9 times the human clinical exposure, based on area under the curve (AUC). In rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 16 times the recommended human dose on a mg/m 2 basis.

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with anastrozole and for at least 3 weeks after the last dose [ see Use in Specific Populations ( 8.1, 8.3) and Clinical Pharmacology (12.1)].

🤒 Adverse Reactions ~3 min read ▾

Serious adverse reactions with anastrozole occurring in less than 1 in 10,000 patients, are: 1) skin reactions such as lesions, ulcers, or blisters; 2) allergic reactions with swelling of the face, lips, tongue, and/or throat. This may cause difficulty in swallowing and/or breathing; and 3) changes in blood tests of the liver function, including inflammation of the liver with symptoms that may include a general feeling of not being well, with or without jaundice, liver pain or liver swelling [ see Adverse Reactions (6.2)].

Common adverse reactions (occurring with an incidence of ≥10%) in women taking anastrozole included: hot flashes, asthenia, arthritis, pain, arthralgia, hypertension, depression, nausea and vomiting, rash, osteoporosis, fractures, back pain, insomnia, headache, bone pain, peripheral edema, increased cough, dyspnea, pharyngitis and lymphedema. In the ATAC trial, the most common reported adverse reaction (>0.1%) leading to discontinuation of therapy for both treatment groups was hot flashes, although there were fewer patients who discontinued therapy as a result of hot flashes in the anastrozole group.

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.

6.1Clinical Trials Experience Adjuvant Therapy Adverse reaction data for adjuvant therapy are based on the ATAC trial [ see Clinical Studies (14.1)]. The median duration of adjuvant treatment for safety evaluation was 59.8 months and 59.6 months for patients receiving anastrozole 1 mg and tamoxifen 20 mg, respectively. Adverse reactions occurring with an incidence of at least 5% in either treatment group during treatment or within 14 days of the end of treatment are presented in Table 1.

Table 1 — Adverse reactions occurring with an incidence of at least 5% in either treatment group during treatment, or within 14 days of the end of treatment in the ATAC trial * Body system and adverse reactions by COSTART † preferred term † Anastrozole 1 mg (N §= 3,092) Tamoxifen 20 mg (N § = 3,094) Body as a whole Asthenia 575 (19) 544 (18) Pain 533 (17) 485 (16) Back pain 321 (10) 309 (10) Headache 314 (10) 249 (8) Abdominal pain 271 (9) 276 (9) Infection 285 (9) 276 (9) Accidental injury 311 (10) 303 (10) Flu syndrome 175 (6) 195 (6) Chest pain 200 (7) 150 (5) Neoplasm 162 (5) 144 (5) Cyst 138 (5) 162 (5) Cardiovascular Vasodilatation 1,104 (36) 1,264 (41) Hypertension 402 (13) 349 (11) Digestive Nausea 343 (11) 335 (11) Constipation 249 (8) 252 (8) Diarrhea 265 (9) 216 (7) Dyspepsia 206 (7) 169 (6) Gastrointestinal disorder 210 (7) 158 (5) Hemic and lymphatic Lymphedema 304 (10) 341 (11) Anemia 113 (4) 159 (5) Metabolic and nutritional Peripheral edema 311 (10) 343 (11) Weight gain 285 (9) 274 (9) Hypercholesterolemia 278 (9) 108 (3.5) Musculoskeletal Arthritis 512 (17) 445 (14) Arthralgia 467 (15) 344 (11) Osteoporosis 325 (11) 226 (7) Fracture 315 (10) 209 (7) Bone pain 201 (7) 185 (6) Arthrosis 207 (7) 156 (5) Joint Disorder 184 (6) 160 (5) Myalgia 179 (6) 160 (5) Nervous system Depression 413 (13) 382 (12) Insomnia 309 (10) 281 (9) Dizziness 236 (8) 234 (8) Anxiety 195 (6) 180 (6) Paresthesia 215 (7) 145 (5) Respiratory Pharyngitis 443 (14) 422 (14) Cough increased 261 (8) 287 (9) Dyspnea 234 (8) 237 (8) Sinusitis 184 (6) 159 (5) Bronchitis 167 (5) 153 (5) Skin and appendages Rash 333 (11) 387 (13) Sweating 145 (5) 177 (6) Special Senses Cataract Specified 182 (6) 213 (7) Urogenital Leukorrhea 86 (3) 286 (9) Urinary tract infection 244 (8) 313 (10) Breast pain 251 (8) 169 (6) Breast Neoplasm 164 (5) 139 (5) Vulvovaginitis 194 (6) 150 (5) Vaginal Hemorrhage ¶ 122 (4) 180 (6) Vaginitis 125 (4) 158 (5) *The combination arm was discontinued due to lack of efficacy benefit at 33 months of follow-up. †COSTART Coding Symbols for Thesaurus of Adverse Reaction Terms. ‡A…

🔄 Drug Interactions 192 words ▾

7.1Tamoxifen Co-administration of anastrozole and tamoxifen in breast cancer patients reduced anastrozole plasma concentration by 27%. However, the co-administration of anastrozole and tamoxifen did not affect the pharmacokinetics of tamoxifen or N-desmethyltamoxifen. At a median follow-up of 33 months, the combination of anastrozole and tamoxifen did not demonstrate any efficacy benefit when compared with tamoxifen in all patients as well as in the hormone receptor-positive subpopulation.

This treatment arm was discontinued from the trial [ see Clinical Studies (14.1)]. Based on clinical and pharmacokinetic results from the ATAC trial, tamoxifen should not be administered with anastrozole.

7.2Estrogen Estrogen-containing therapies should not be used with anastrozole as they may diminish its pharmacological action.

7.3Warfarin In a study conducted in 16 male volunteers, anastrozole did not alter the exposure (as measured by Cmax and AUC) and anticoagulant activity (as measured by prothrombin time, activated partial thromboplastin time, and thrombin time) of both R- and S-warfarin.

7.4Cytochrome P450 Based on in vitro and in vivo results, it is unlikely that co-administration of anastrozole 1 mg will affect other drugs as a result of inhibition of cytochrome P450 [see Clinical Pharmacology (12.3)].

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, anastrozole may cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1)]. There are no studies of anastrozole use in pregnant women. Anastrozole caused embryo-fetal toxicities in rats at maternal exposure that were 9 times the human clinical exposure, based on area under the curve (AUC).

In rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 16 times the recommended human dose on a mg/m2 basis. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In animal reproduction studies, pregnant rats and rabbits received anastrozole during organogenesis at doses equal to or greater than 0.1 and 0.02 mg/kg/day, respectively, (about 1 and 1/3 the recommended human dose on a mg/m 2 basis, respectively). In both species, anastrozole crossed the placenta, and there was increased pregnancy loss (increased pre- and/or post-implantation loss, increased resorption, and decreased numbers of live fetuses).

In rats, these effects were dose related, and placental weights were significantly increased at doses equal to or greater than 0.1 mg/kg/day. Fetotoxicity, including delayed fetal development (i.e., incomplete ossification and depressed fetal body weights), occurred in rats at anastrozole doses of 1 mg/kg/day that produced peak plasma levels 19 times higher than serum levels in humans at the therapeutic dose (AUC 0-24 hr 9 times higher). In rabbits, anastrozole caused pregnancy failure at doses equal to or greater than 1.0 mg/kg/day (about 16 times the recommended human dose on a mg/m 2 basis).

8.2Lactation Risk Summary There are no data on the presence of anastrozole or its metabolites in human milk, or its effects on the breast-fed child or on milk production. Because many drugs are excreted in human milk and because of the tumorigenicity shown for anastrozole in animal studies, or the potential for serious adverse reactions in the breast-fed child from anastrozole, advise lactating women not to breastfeed during treatment with anastrozole and for 2 weeks after the last dose.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiation of anastrozole. Contraception Females Based on animal studies, anastrozole can cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1)]. Advise females of reproductive potential to use effective contraception during treatment with anastrozole tablets and for at least 3 weeks after the last dose.

Infertility Females Based on studies in female animals, anastrozole may impair fertility in females of reproductive potential [ see Nonclinical Toxicology (13.1)].

8.4Pediatric Use Clinical studies in pediatric patients included a placebo-controlled trial in pubertal boys of adolescent age with gynecomastia and a single-arm trial in girls with McCune-Albright Syndrome and progressive precocious puberty. The efficacy of anastrozole tablets in the treatment of pubertal gynecomastia in adolescent boys and in the treatment of precocious puberty in girls with McCune-Albright Syndrome has not been demonstrated. Gynecomastia Study A randomized, double-blind, placebo-controlled, multi-center study enrolled 80 boys with pubertal gynecomastia aged 11 to 18 years.

Patients were randomized to a daily regimen of either anastrozole tablets 1 mg or placebo. After 6 months of treatment there was no statistically significant difference in the percentage of patients who experienced a ≥50% reduction in gynecomastia (primary e…

🆘 Overdosage 115 words ▾

Clinical trials have been conducted with anastrozole, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were tolerated. A single dose of anastrozole that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage and treatment must be symptomatic.

In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because anastrozole is not highly protein bound.

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

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action The growth of many cancers of the breast is stimulated or maintained by estrogens. In postmenopausal women, estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens (primarily androstenedione and testosterone) to estrone and estradiol. The suppression of estrogen biosynthesis in peripheral tissues and in the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme.

Anastrozole is a selective non-steroidal aromatase inhibitor. It significantly lowers serum estradiol concentrations and has no detectable effect on formation of adrenal corticosteroids or aldosterone.

12.2Pharmacodynamics Effect on Estradiol Mean serum concentrations of estradiol were evaluated in multiple daily dosing trials with 0.5, 1, 3, 5, and 10 mg of anastrozole in postmenopausal women with advanced breast cancer. Clinically significant suppression of serum estradiol was seen with all doses. Doses of 1 mg and higher resulted in suppression of mean serum concentrations of estradiol to the lower limit of detection (3.7 pmol/L).

The recommended daily dose, anastrozole 1 mg, reduced estradiol by approximately 70% within 24 hours and by approximately 80% after 14 days of daily dosing. Suppression of serum estradiol was maintained for up to 6 days after cessation of daily dosing with anastrozole 1 mg. The effect of anastrozole in premenopausal women with early or advanced breast cancer has not been studied.

Because aromatization of adrenal androgens is not a significant source of estradiol in premenopausal women, anastrozole would not be expected to lower estradiol levels in premenopausal women. Effect on Corticosteroids In multiple daily dosing trials with 3, 5, and 10 mg, the selectivity of anastrozole was assessed by examining effects on corticosteroid synthesis. For all doses, anastrozole did not affect cortisol or aldosterone secretion at baseline or in response to ACTH.

No glucocorticoid or mineralocorticoid replacement therapy is necessary with anastrozole. Other Endocrine Effects In multiple daily dosing trials with 5 and 10 mg, thyroid stimulating hormone (TSH) was measured; there was no increase in TSH during the administration of anastrozole. Anastrozole does not possess direct progestogenic, androgenic, or estrogenic activity in animals, but does perturb the circulating levels of progesterone, androgens, and estrogens.

12.3Pharmacokinetics Absorption Inhibition of aromatase activity is primarily due to anastrozole, the parent drug. Absorption of anastrozole is rapid and maximum plasma concentrations typically occur within 2 hours of dosing under fasted conditions. Studies with radiolabeled drug have demonstrated that orally administered anastrozole is well absorbed into the systemic circulation.

Food reduces the rate but not the overall extent of anastrozole absorption. The mean Cmax of anastrozole decreased by 16% and the median Tmax was delayed from 2 to 5 hours when anastrozole was administered 30 minutes after food. The pharmacokinetics of anastrozole are linear over the dose range of 1 to 20 mg, and do not change with repeated dosing.

The pharmacokinetics of anastrozole were similar in patients and healthy volunteers. Distribution Steady-state plasma levels are approximately 3- to 4-fold higher than levels observed after a single dose of anastrozole. Plasma concentrations approach steady-state levels at about 7 days of once daily dosing.

Anastrozole is 40% bound to plasma proteins in the therapeutic range. Metabolism Metabolism of anastrozole occurs by N-dealkylation, hydroxylation and glucuronidation. Three metabolites of anastrozole (triazole, a glucuronide conjugate of hydroxy-anastrozole, and a glucuronide conjugate of anastrozole itself) have been identified in human plasma and urine.

The major circulating metabolite of anastrozole, triazole, lacks pharmacologic activity. Anastrozole inhibited reactions catalyzed by cytochrome P450 1…

📦 How Supplied / Storage and Handling 49 words ▾

Anastrozole Tablets, USP 1 mg are white, circular, biconvex tablets, debossed with ‘YL’ on one side, and ‘111’ on the other side. Anastrozole Tablets, USP 1 mg are supplied in bottles of 30 tablets (NDC 72189-682-30), bottles of 90 tablets (NDC 23155-857-09) and bottles of 500 tablets (NDC 23155-857-05).

📦 Storage and Handling 12 words ▾

Storage Store at 20°to 25°C (68°to 77°F) [see USP Controlled Room Temperature].

📋 Description 113 words ▾

Anastrozole Tablets，USP for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C 17H 19N 5 and its structural formula is: [Chemical Structure for anastrozole] Anastrozole, USP is an off-white powder with a molecular weight of 293.4.

Anastrozole, USP has moderate aqueous solubility (0.5 mg/mL at 25°C); solubility is independent of pH in the physiological range. Anastrozole, USP is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile. Each tablet contains as inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol sodium starch glycolate, and titanium dioxide .

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 72189-0681-30 · Direct_Rx 72189-0683-30 · Direct_Rx →
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.