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Capecitabine 150mg 150 mg Tablet, Film Coated, 60-count — NDC 72485-204-60 (Billing 72485-0204-60)

by Armas Pharmaceuticals Inc. · 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE

This is a package of 60 tablets of Capecitabine 150mg 150 mg Tablet, Film Coated from Armas Pharmaceuticals Inc., marketed since Mar 2019 and currently FDA-listed. It is this product's only package size.

NDC 72485-0204-60
🏷️ FDA NDC (as labeled) 72485-204-60 billing pads the product segment with a zero
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 →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 72485-204-60 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72485 labeler · 204 product · 60 package
Package marketed since
Mar 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
60 EA per package
Barcode (UPC-A, from the NDC)
3 7248520460 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72485-204-60
Product NDC 72485-204
11-digit billing NDC 72485020460
NCPDP billing unit EA — each (per item)
RxCUI 200327
UNII 6804DJ8Z9U
Application # ANDA207456
SPL Set ID 7f555b6b-60db-45e2-a61e-537e57f43fdc
Established class (EPC) Nucleoside Metabolic Inhibitor
Mechanism of action Nucleic Acid Synthesis Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-03-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance CAPECITABINE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 21300005000320
GPI class Capecitabine
GCN Seq No 039780
GCN 31611
HICL code 018385
Ingredient (HICL) Capecitabine
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V1
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs
HIC3 code V1B
Therapeutic class — specific (HIC3) Antineoplastic - Antimetabolites
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name CAPECITABINE 150 MG TABLET
FDB brand name Capecitabine
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 039780
  • GCN: 31611
  • GPI-14 (Medi-Span): 21300005000320
  • HICL (First Databank): 018385
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 200327
Why two NDCs? The FDA registers this code as 72485-204-60 — 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 → 72485-0204-60. 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 Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Pyrimidine analogues
How it works Nucleic Acid Synthesis 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.

Clinical

Label name CAPECITABINE 150 MG TABLET Ingredient Capecitabine
📗 Our plain-language guide HelloPharmacist
  • Capecitabine is used for several types of cancer — most commonly colorectal (colon and rectal) cancer, advanced or metastatic breast cancer, and, depending on the product, cancers...
  • What kinds of cancer does capecitabine treat?
  • Yes — this one really matters. You should take capecitabine within 30 minutes after eating a meal, and swallow the tablets whole with water. Taking it on an empty stomach significa...
  • The most common side effects are hand-and-foot syndrome (redness, soreness, or peeling on your palms and soles), diarrhea, nausea, fatigue, and mouth sores. Many of these can be ma...
📖 Read our full Capecitabine guide →
1
Nutrient depletion considerations

Capecitabine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Capecitabine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · NONE No ASP payment limit on file for NONE this quarter.
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.

Billing & reimbursement

FDA NDC (as labeled)72485-204-60
11-digit billing NDC72485-0204-60
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeNONE
DescriptorCAPECITABINE, ORAL, 50 MG
Billing units / pkg3 units
How the units are derivedThis package is 60 EA; the HCPCS unit is 50 MG, so one package = 3 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72485-0204-60 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE 2019-03-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Capecitabine 150 mg 00093-7473-06 Teva 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 16729-0072-12 Accord 60 tablets $0.362 AB Availability likely —
capecitabine 150 mg 31722-0774-60 Camber 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 68001-0487-06 BluePoint 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 68001-0643-06 BluePoint 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 69097-0949-03 Cipla 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 70756-0815-60 Lifestar 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 72205-0006-60 Novadoz 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 82249-0207-60 CivicaScript 60 tablets $0.362 AB Availability likely —
Capecitabine 150 mg 51407-0639-60 Golden 60 tablets — AB FDA listed —
capecitabine 150 mg 55111-0496-05 Dr. 500 tablets — AB FDA listed —
Capecitabine 150 mg 59651-0204-10 Aurobindo 10 tablets — AB FDA listed —
Capecitabine 150 mg 62756-0238-18 Sun 1000 tablets — — FDA listed —
Capecitabine 150 mg 67877-0458-12 Ascend 120 tablets — AB FDA listed —
Capecitabine 150mg 150 mgthis 72485-0204-60 Armas 60 tablets — AB FDA listed —
Capecitabine 150 mg 82511-0001-15 Teyro 60 tablets — BX 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

🏛️
2019
On the market since
Mar 2019
📍
2026
Currently FDA-listed
7 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerArmas Pharmaceuticals Inc.
Application holderSHILPA MEDICARE LTD
FDA applicationANDA207456 (ANDA)
Labeler code72485
First marketedMar 2019
Product typeHuman Prescription Drug
Portfolio61 products on file

More NDCs from Armas Pharmaceuticals Inc. labeler code 72485

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.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Patient Medication Information 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📚 References 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: CAPECITABINE-WARFARIN INTERACTION Capecitabine Warfarin Interaction: Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly. A clinically important capecitabine-Warfarin drug interaction was demonstrated in a clinical pharmacology trial [see Warnings and Precautions (5.2) and Drug Interactions (7.1) ] . Altered coagulation parameters and/or bleeding, including death, have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon.

Post marketing reports have shown clinically significant increases in prothrombin time (PT) and INR in patients who were stabilized on anticoagulants at the time capecitabine was introduced. These events occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. These events occurred in patients with and without liver metastases.

Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy. WARNING: CAPECITABINE -WARFARIN INTERACTION See full prescribing information for complete boxed warning. Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulants such as warfarin and phenprocoumon should have their anticoagulant response (INR or prothrombin time) monitored frequently in order to adjust the anticoagulant dose accordingly.

Altered coagulation parameters and/or bleeding, including death, have been reported during concomitant use. Occurrence: Within several days and up to several months after initiating capecitabine therapy; may also be seen within 1 month after stopping capecitabine Predisposing factors: age>60 and diagnosis of cancer

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Capecitabine tablets are a nucleoside metabolic inhibitor with antineoplastic activity indicated for: • Adjuvant Colon Cancer (1.1) – Patients with Dukes' C colon cancer • Metastatic Colorectal Cancer (1.1) – First-line as monotherapy when treatment with fluoropyrimidine therapy alone is preferred • Metastatic Breast Cancer (1.2) – In combination with docetaxel after failure of prior anthracycline containing therapy – As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regimen

1.1Colorectal Cancer Capecitabine tablets are indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Capecitabine tablets are non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent capecitabine tablets in the adjuvant treatment of Dukes' C colon cancer.

Capecitabine tablets are indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with capecitabine tablets monotherapy.

Use of capecitabine tablets instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.

1.2Breast Cancer Capecitabine tablets in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. Capecitabine tablets monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m 2 of doxorubicin or doxorubicin equivalents).

Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take capecitabine tablets with water within 30 min after a meal (2.1) Monotherapy: 1250 mg/m 2 twice daily orally for 2 weeks followed by a one week rest period in 3-week cycles (2.2) Adjuvant treatment is recommended for a total of 6 months (8 cycles) (2.2) In combination with docetaxel, the recommended dose of capecitabine tablets is 1250 mg/m 2 twice daily for 2 weeks followed by a 7-day rest period, combined with docetaxel at 75 mg/m 2 as a 1-hour IV infusion every 3 weeks (2.2) Capecitabine tablets dosage may need to be individualized to optimize patient management (2.3) Reduce the dose of capecitabine tablets by 25% in patients with moderate renal impairment (2.4)

2.1Important Administration Instructions Capecitabine tablets should be swallowed whole with water within 30 minutes after a meal. Capecitabine is a cytotoxic drug. Follow applicable special handling and disposal procedures.

1 If Capecitabine tablets must be cut or crushed, this should be done by a professional trained in safe handling of cytotoxic drugs using appropriate equipment and safety procedures. Capecitabine Tablets dose is calculated according to body surface area.

2.2Standard Starting Dose Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer) The recommended dose of capecitabine tablets are 1250 mg/m 2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m 2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles (see Table 1 ). Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [ie, capecitabine tablets 1250 mg/m 2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)].

Table 1 Capecitabine Tablets Dose Calculation According to Body Surface Area Dose Level 1250 mg/m 2 Twice a Day Number of Tablets to be Taken at Each Dose (Morning and Evening) Surface Area (m 2 ) Total Daily Dose Total Daily Dose divided by 2 to allow equal morning and evening doses (mg) 150mg 500mg ≤ 1.25 3000 0 3 1.26-1.37 3300 1 3 1.38-1.51 3600 2 3 1.52-1.65 4000 0 4 1.66-1.77 4300 1 4 1.78-1.91 4600 2 4 1.92-2.05 5000 0 5 2.06-2.17 5300 1 5 ≥ 2.18 5600 2 5 In Combination With Docetaxel (Metastatic Breast Cancer) In combination with docetaxel, the recommended dose of capecitabine tablets are 1250 mg/m 2 twice daily for 2 weeks followed by a 1-week rest period, combined with docetaxel at 75 mg/m 2 as a 1-hour intravenous infusion every 3 weeks.

Pre-medication, according to the docetaxel labeling, should be started prior to docetaxel administration for patients receiving the capecitabine tablets plus docetaxel combination. Table 1 displays the total daily dose of capecitabine tablets by body surface area and the number of tablets to be taken at each dose.

2.3Dose Management Guidelines General Capecitabine tablets dosage may need to be individualized to optimize patient management. Patients should be carefully monitored for toxicity and doses of capecitabine tablets should be modified as necessary to accommodate individual patient tolerance to treatment [see Clinical Studies (14) ] . Toxicity due to capecitabine tablets administration may be managed by symptomatic treatment, dose interruptions and adjustment of capecitabine tablets dose.

Once the dose has been reduced, it should not be increased at a later time. Doses of capecitabine tablets omitted for toxicity are not replaced or restored; instead the patient should resume the planned treatment cycles. The dose of phenytoin and the dose of coumarin-derivative anticoagulants may need to be reduced when either drug is administered concomitantly with capecitabine tablets [see Drug Interactions (7.1) ] .

Monotherapy (Metastatic Colorectal Cancer, Adjuvant Colorectal Cancer, Metastatic Breast Cancer) Capecitabine tablets dose modification scheme as described below (see Table 2 ) is recommended for… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 70 words ▾

3 DOSAGE FORMS AND STRENGTHS Capecitabine tablets USP are supplied in strengths of 150 mg and 500 mg for oral administration. 150 mg : Light pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 150. 500 mg : Dark pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 500. Tablets: 150 mg and 500 mg (3)

⛔ Contraindications 74 words ▾

4 CONTRAINDICATIONS Severe Renal Impairment (4.1) Hypersensitivity (4.2)

4.1Severe Renal Impairment Capecitabine tablets are contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] .

4.2Hypersensitivity Capecitabine tablets are contraindicated in patients with known hypersensitivity to capecitabine or to any of its components. Capecitabine tablets are contraindicated in patients who have a known hypersensitivity to 5-fluorouracil.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Coagulopathy: May result in bleeding, death. Monitor anticoagulant response (e.g., INR) and adjust anticoagulant dose accordingly. (5.1) Diarrhea: May be severe.

Interrupt Capecitabine tablets treatment immediately until diarrhea resolves or decreases to grade 1. Recommend standard antidiarrheal treatments. (5.2) Cardiotoxicity: Common in patients with a prior history of coronary artery disease.

(5.3) Increased Risk of Severe or Fatal Adverse Reactions in Patients with Lo w or Absent Dihydropyrimidine Dehydrogenase (DPD) Activity: Withhold or permanently discontinue Capecitabine tablets in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity. No Capecitabine tablets dose has been proven safe in patients with absent DPD activity. ( 5.4 ) Dehydration and Renal Failure: Interrupt Capecitabine tablets treatment until dehydration is corrected.

Potential risk of acute renal failure secondary to dehydration. Monitor and correct dehydration. (5.5) .

Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. (5.6 , 8.1, 8.3) Mucocutaneous and Dermatologic Toxicity: Severe mucocutaneous reactions, Steven-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), have been reported.

Capecitabine tablets should be permanently discontinued in patients who experience a severe mucocutaneous reaction during treatment. Capecitabine tablets may induce hand-and-foot syndrome. Persistent or severe hand-and-foot syndrome can lead to loss of fingerprints which could impact patient identification.

In Interrupt Capecitabine tablets treatment until the hand-and-foot syndrome event resolves or decreases in intensity. (5.7) Hyperbilirubinemia: Interrupt capecitabine tablet treatment immediately until the hyperbilirubinemia resolves or decreases in intensity. (5.8) Hematologic: Do not treat patients with neutrophil counts <1.5 x 10 9 /L or thrombocyte counts <100 x 10 9 /L.

If grade 3-4 neutropenia or thrombocytopenia occurs, stop therapy until condition resolves. (5.9)

5.1Coagulopathy Patients receiving concomitant capecitabine and oral coumarin-derivative anticoagulant therapy should have their anticoagulant response (INR or prothrombin time) monitored closely with great frequency and the anticoagulant dose should be adjusted accordingly [see Boxed Warning and Drug Interactions (7.1) ]

5.2Diarrhea Capecitabine can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. In 875 patients with either metastatic breast or colorectal cancer who received capecitabine monotherapy, the median time to first occurrence of grade 2 to 4 diarrhea was 34 days (range from 1 to 369 days).

The median duration of grade 3 to 4 diarrhea was 5 days. National Cancer Institute of Canada (NCIC) grade 2 diarrhea is defined as an increase of 4 to 6 stools/day or nocturnal stools, grade 3 diarrhea as an increase of 7 to 9 stools/day or incontinence and malabsorption, and grade 4 diarrhea as an increase of ≥10 stools/day or grossly bloody diarrhea or the need for parenteral support. If grade 2, 3 or 4 diarrhea occurs, administration of capecitabine should be immediately interrupted until the diarrhea resolves or decreases in intensity to grade 1. [see Dosage and Administration (2.3) ] .

Standard antidiarrheal treatments (eg, loperamide) are recommended. Necrotizing enterocolitis (typhlitis) has been reported.

5.3Cardiotoxicity The cardiotoxicity observed with capecitabine tablets includes myocardial infarction/ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, electrocardiographic changes, and cardiomyopathy. These adverse reactions may be more common in patients with a prior history of coronary artery disease.

5.4Dihydropyrimidine D… [Excerpted — this section continues on DailyMed.]

🤒 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. Most common adverse reactions (≥30%) were diarrhea, hand-and-foot syndrome, nausea, vomiting, abdominal pain, fatigue/weakness, and hyperbilirubinemia. Other adverse reactions, including serious adverse reactions, have been reported.

(6) To report SUSPECTED ADVERSE REACTIONS, contact 1-888-557-1212 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Adjuvant Colon Cancer Table 4 shows the adverse reactions occurring in ≥5% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment. A total of 995 patients were treated with 1250 mg/m 2 twice a day of capecitabine administered for 2 weeks followed by a 1-week rest period, and 974 patients were administered 5- FU and leucovorin (20 mg/m 2 leucovorin IV followed by 425 mg/m 2 IV bolus 5-FU on days 1-5 every 28 days).

The median duration of treatment was 164 days for capecitabine-treated patients and 145 days for 5-FU/LV-treated patients. A total of 112 (11%) and 73 (7%) capecitabine and 5-FU/LV-treated patients, respectively, discontinued treatment because of adverse reactions. A total of 18 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 8 (0.8%) patients randomized to capecitabine and 10 (1.0%) randomized to 5-FU/LV.

Table 5 shows grade 3/4 laboratory abnormalities occurring in ≥1% of patients from one phase 3 trial in patients with Dukes' C colon cancer who received at least one dose of study medication and had at least one safety assessment. Table 4 Percent Incidence of Adverse Reactions Reported in ≥5% of Patients Treated With Capecitabine or 5-FU/LV for Colon Cancer in the Adjuvant Setting (Safety Population) Adjuvant Treatment for Colon Cancer (N=1969) Capecitabine (N=995) 5-FU/LV (N=974) Body System/ Adverse Event All Grades Grade 3/4 All Grades Grade 3/4 Gastrointestinal Disorders Diarrhea 47 12 65 14 Nausea 34 2 47 2 Stomatitis 22 2 60 14 Vomiting 15 2 21 2 Abdominal Pain 14 3 16 2 Constipation 9 - 11 <1 Upper Abdominal Pain 7 <1 7 <1 Dyspepsia 6 <1 5 - Skin and Subcutaneous Tissue Disorders Hand-and-Foot Syndrome 60 17 9 <1 Alopecia 6 - 22 <1 Rash 7 - 8 - Erythema 6 1 5 <1 General Disorders and Administration Site Conditions Fatigue 16 <1 16 1 Pyrexia 7 <1 9 <1 Asthenia 10 <1 10 1 Lethargy 10 <1 9 <1 Nervous System Disorders Dizziness 6 <1 6 - Headache 5 <1 6 <1 Dysgeusia 6 - 9 - Metabolism and Nutrition Disorders Anorexia 9 <1 11 <1 Eye Disorders Conjunctivitis 5 <1 6 <1 Blood and Lymphatic System Disorders Neutropenia 2 <1 8 5 Respiratory Thoracic and Mediastinal Disorders Epistaxis 2 - 5 - Table 5 Percent Incidence of Grade 3/4 Laboratory Abnormalities Reported in ≥1% of Patients Receiving Capecitabine Monotherapy for Adjuvant Treatment of Colon Cancer (Safety Population) Adverse Event Capecitabine (n=995) Grade 3/4 % IV 5-FU/LV (n=974) Grade 3/4 % Increased ALAT (SGPT) Increased calcium Decreased calcium Decreased hemoglobin Decreased lymphocytes Decreased neutrophils The incidence of grade 3/4 white blood cell abnormalities was 1.3% in the capecitabine arm and 4.9% in the IV 5-FU/LV arm. ** It should be noted that grading was according to NCIC CTC Version 1 (May, 1994).

In the NCIC-CTC Version 1, hyperbilirubinemia grade 3 indicates a bilirubin value of 1.5 to 3.0 x upper limit of normal (ULN) range, and grade 4 a value of > 3.0 x ULN. The NCI CTC Version2 and above define a grade 3 bilirubin value of >3.0 to 10.0 x ULN, and grade 4 values >10.0 x ULN. Decreased neutrophils/granulocytes Decreased platelets Increased bilirubin ** 1.6 1.1 2.3 1.0 13.0 2.2 2.4 1.0 20 0.6 0.7 2.2 1.2 13.0 26.2 26.4 0.7 6.3

6.2Metastatic Colorectal Cancer Mo… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Anticoagulants: Monitor anticoagulant response (INR or prothrombin time) frequently in order to adjust the anticoagulant dose as needed. (5.2 , 7.1) Phenytoin: Monitor phenytoin levels in patients taking capecitabine concomitantly with phenytoin. The phenytoin dose may need to be reduced.

(7.1) Leucovorin: The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin. (7.1) CYP2C9 substrates: Care should be exercised when capecitabine is coadministered with CYP2C9 substrates. (7.1) Allopurinol: Avoid the use of allopurinol during treatment with Capecitabine tablets.

Food reduced both the rate and extent of absorption of capecitabine. (2 , 7.2 , 12.3)

7.1Drug-Drug Interactions Anticoagulants Altered coagulation parameters and/or bleeding have been reported in patients taking capecitabine concomitantly with coumarin-derivative anticoagulants such as warfarin and phenprocoumon [ see Boxed Warning ]. These events occurred within several days and up to several months after initiating capecitabine therapy and, in a few cases, within 1 month after stopping capecitabine. These events occurred in patients with and without liver metastases.

In a drug interaction study with single dose warfarin administration, there was a significant increase in the mean AUC of S-warfarin [ see Clinical Pharmacology ( 12.3 ) ]. The maximum observed INR value increased by 91%. This interaction is probably due to an inhibition of cytochrome P450 2C9 by capecitabine and/or its metabolites.

Phenytoin The level of phenytoin should be carefully monitored in patients taking capecitabine and phenytoin dose may need to be reduced [ see Dosage and Administration ( 2.3 ) ]. Postmarketing reports indicate that some patients receiving capecitabine and phenytoin had toxicity associated with elevated phenytoin levels. Formal drug-drug interaction studies with phenytoin have not been conducted, but the mechanism of interaction is presumed to be inhibition of the CYP2C9 isoenzyme by capecitabine and/or its metabolites.

Leucovorin The concentration of 5-fluorouracil is increased and its toxicity may be enhanced by leucovorin. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly leucovorin and fluorouracil. CYP2C9 substrates Other than warfarin, no formal drug-drug interaction studies between capecitabine and other CYP2C9 substrates have been conducted.

Care should be exercised when capecitabine is coadministered with CYP2C9 substrates. Allopurinol Concomitant use with allopurinol may decrease concentration of capecitabine’s active metabolites [ see Clinical Pharmacology ( 12.3 ) ], which may decrease capecitabine tablets efficacy. Avoid the use of allopurinol during treatment with capecitabine tablets.

7.2Drug-Food Interaction Food was shown to reduce both the rate and extent of absorption of capecitabine [see Clinical Pharmacology (12.3) ] . In all clinical trials, patients were instructed to administer capecitabine within 30 minutes after a meal. It is recommended that capecitabine be administered with food [see Dosage and Administration (2) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Advise women not to breast feeding. (8.2) Females and males of reproductive potential: Verify pregnancy status of females prior to initiation of Capecitabine tablets. Advise males with female partners of reproductive potential to use effective contraception.

(8.3) Geriatric: Greater incidence of adverse reactions. Monitoring required. (8.5) Hepatic Impairment: Monitoring is recommended in patients with mild to moderate hepatic impairment.

(8.6) Renal Impairment: Reduce capecitabine starting dose in patients with moderate renal impairment ( 2.4 , 8.7 , 12.3)

8.1Pregnancy: Risk Summary Based on findings in animal reproduction studies and its mechanism of action, Capecitabine can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . Limited available human data are not sufficient to inform the drug-associated risk during pregnancy. In animal reproduction studies, administration of capecitabine to pregnant animals during the period of organogenesis caused embryo lethality in monkeys at 0.2 and 0.6 times the exposure (AUC) in patients receiving the recommended dose respectively[see Data].

Apprise pregnant women of the potential risk to a fetus. The estimated 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 recognised pregnancies is 2-4% and 15-20% respectively.

Data Animal Data Oral administration of capecitabine to pregnant mice during the period of organogenesis at a dose of 198mg/kg/day caused malformations and embryo lethality. In separate pharmacokinetic studies, this dose in mice produced 5'-DFURAUC values that were approximately 0.2 times the AUC values in patients administered the recommended daily dose. Malformations in mice included cleft palate, anopthalmia, micropthalmia, oligodactyly, polydactyly, syndactyly, kinky tail and dilation of cerebral ventricles.

Oral administration of capecitabine to pregnant monkeys during the period of organogenesis at a dose of 90mg/kg/day, caused fetal lethality. This dose produced 5'-DFURAUC values that were approximately 0.6 times the AUC values in patients administered the recommended daily dose.

8.2Lactation Risk Summary There is no information regarding the presence of capecitabine in human milk, or on its effect on milk production or the breast-fed infant. Capecitabine metabolites were present in the milk of lactating mice [see Data]. Because of the potential for serious adverse reactions from capecitabine exposure in breast-fed infants, advise women not to breastfeed during treatment with capecitabine and for 2 weeks after the final dose.

Data Lactating mice given a single oral dose of capecitabine excreted significant amounts of capecitabine metabolise into the milk

8.3Females and Males of Reproductive Potential Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating capecitabine. Contraception Females Capecitabine 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 and for 6 months following the final dose of capecitabine.

Males Based on genetic toxicity findings, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months following the last dose of capecitabine [see Nonclinical Toxicology (13.1) ] Infertility Based on animal studies, capecitabine may impair fertility in females and males of reproductive potential [see Nonclinical Toxicology (13.1) ]

8.4Pediatric Use The safety and effectiveness of capecitabine tablets in pediatric patients have not been established. No clinical benefit was demonstrated in two single arm trials in pediatric patients with newly diagnosed brainst… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of capecitabine tablets in pediatric patients have not been established. No clinical benefit was demonstrated in two single arm trials in pediatric patients with newly diagnosed brainstem gliomas and high grade gliomas. In both trials, pediatric patients received an investigational pediatric formulation of capecitabine concomitantly with and following completion of radiation therapy (total dose of 5580 cGy in 180 cGy fractions).

The relative bioavailability of the investigational formulation to capecitabine was similar. The first trial was conducted in 22 pediatric patients (median age 8 years, range 5-17 years) with newly diagnosed non-disseminated intrinsic diffuse brainstem gliomas and high grade gliomas. In the dose-finding portion of the trial, patients received capecitabine with concomitant radiation therapy at doses ranging from 500 mg/m 2 to 850 mg/m 2 every 12 hours for upto 9 weeks.

After a 2 week break, patients received 1250 mg/m 2 capecitabine every 12 hours on Days 1-14 of a 21day cycle for upto 3 cycles. The maximum tolerated dose (MTD) of capecitabine administered concomitantly with radiation therapy was 650 mg/m 2 every 12 hours. The major dose limiting toxicities were palmar-plantar erythrodysesthesia and alanine aminotransferase(ALT) elevation.

The second trial was conducted in 34 additional pediatric patients with newly diagnosed non-disseminated intrinsic diffuse brainstem gliomas (median age 7 years, range 3-16 years) and 10 pediatric patients who received the MTD of capecitabine in the dose-finding trial and met the eligibility criteria for this trial. All patients received 650 mg/m 2 capecitabine every 12 hours with concomitant radiation therapy for upto 9 weeks. After a 2 week break, patients received 1250 mg/m 2 capecitabine every 12 hours on Days 1-14 of a 21-day cycle for upto 3 cycles.

There was no improvement in one-year progression-fee survival rate and one-year overall survival rate in pediatric patients with newly diagnosed intrinsic brainstem gliomas who received capecitabine relative to a similar population of pediatric patients who participated in other clinical trials. The adverse reaction profile of capecitabine was consistent with the known adverse reaction profile in adults, with the exception of laboratory abnormalities which occurred more commonly in pediatric patients. The most frequently reported laboratory abnormalities (per-patient incidence ≥40%) were increased ALT (75%), lymphocytopenia (73%), leukopenia (73%), hypokalemia (68%), thrombocytopenia (57%), hypoalbuminemia (55%), neutropenia (50%), low hematocrit (50%), hypoclacemia (48%),hypophosphatemia (45%) and hyponatremia (45%).

🧓 Geriatric Use 27 words ▾

8.5Geriatric Use Physicians should pay particular attention to monitoring the adverse effects of capecitabine in the elderly [ see Warnings and Precautions ( 5.10 ) ].

🆘 Overdosage 103 words ▾

10 OVERDOSAGE The manifestations of acute overdose would include nausea, vomiting, diarrhea, gastrointestinal irritation and bleeding, and bone marrow depression. Medical management of overdose should include customary supportive medical interventions aimed at correcting the presenting clinical manifestations. Although no clinical experience using dialysis as a treatment for capecitabine overdose has been reported, dialysis may be of benefit in reducing circulating concentrations of 5'-DFUR, a low–molecular-weight metabolite of the parent compound.

Single doses of capecitabine were not lethal to mice, rats, and monkeys at doses up to 2000 mg/kg (2.4, 4.8, and 9.6 times the recommended human daily dose on a mg/m 2 basis).

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Enzymes convert capecitabine to 5-fluorouracil (5-FU) in vivo . Both normal and tumor cells metabolize 5-FU to 5-fluoro-2'-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). These metabolites cause cell injury by two different mechanisms.

First, FdUMP and the folate cofactor, N 5-10 -methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2'-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division.

Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.

12.3Pharmacokinetics Absorption Following oral administration of 1255 mg/m 2 BID to cancer patients, capecitabine reached peak blood levels in about 1.5 hours (T max ) with peak 5-FU levels occurring slightly later, at 2 hours. Food reduced both the rate and extent of absorption of capecitabine with mean C max and AUC 0-∞ decreased by 60% and 35%, respectively. The C max and AUC 0-∞ of 5-FU were also reduced by food by 43% and 21%, respectively.

Food delayed T max of both parent and 5-FU by 1.5 hours [see Warnings and Precautions (5) , Dosage and Administration (2) , and Drug-Food Interaction (7.2) ] . The pharmacokinetics of capecitabine and its metabolites have been evaluated in about 200 cancer patients over a dosage range of 500 to 3500 mg/m 2 /day. Over this range, the pharmacokinetics of capecitabine and its metabolite, 5'-DFCR were dose proportional and did not change over time.

The increases in the AUCs of 5'-DFUR and 5-FU, however, were greater than proportional to the increase in dose and the AUC of 5-FU was 34% higher on day 14 than on day 1. The interpatient variability in the C max and AUC of 5-FU was greater than 85%. Distribution Plasma protein binding of capecitabine and its metabolites is less than 60% and is not concentration-dependent.

Capecitabine was primarily bound to human albumin (approximately 35%). Capecitabine tablet has a low potential for pharmacokinetic interactions related to plasma protein binding. Bioactivation and Metabolism Capecitabine is extensively metabolized enzymatically to 5-FU.

In the liver, a 60 kDa carboxylesterase hydrolyzes much of the compound to 5'-deoxy-5-fluorocytidine (5'-DFCR). Cytidine deaminase, an enzyme found in most tissues, including tumors, subsequently converts 5'DFCR to 5'-DFUR. The enzyme, thymidine phosphorylase (dThdPase), then hydrolyzes 5'-DFUR to the active drug 5-FU.

Many tissues throughout the body express thymidine phosphorylase. Some human carcinomas express this enzyme in higher concentrations than surrounding normal tissues. Following oral administration of capecitabine 7 days before surgery in patients with colorectal cancer, the median ratio of 5-FU concentration in colorectal tumors to adjacent tissues was 2.9 (range from 0.9 to 8.0).

These ratios have not been evaluated in breast cancer patients or compared to 5-FU infusion. Metabolic Pathway of capecitabine to 5-FU3 The enzyme dihydropyrimidine dehydrogenase hydrogenates 5-FU, the product of capecitabine metabolism, to the much less toxic 5-fluoro-5, 6-dihydro-fluorouracil (FUH 2 ). Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureido-propionic acid (FUPA).

Finally, β-ureido- propionase cleaves FUPA to α-fluoro-β-alanine (FBAL) which is cleared in the urine. In vitro enzymatic studies with human liver microsomes indicated that capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5-FU, and FBAL) did not inhibit the metabolism of test substrates by cytochrome P450 isoenzymes 1A2, 2A6, 3A4, 2C19, 2D6, and 2E1. Excretion Capecitabine and its metabolites are predominan… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 124 words ▾

12.1Mechanism of Action Enzymes convert capecitabine to 5-fluorouracil (5-FU) in vivo . Both normal and tumor cells metabolize 5-FU to 5-fluoro-2'-deoxyuridine monophosphate (FdUMP) and 5-fluorouridine triphosphate (FUTP). These metabolites cause cell injury by two different mechanisms.

First, FdUMP and the folate cofactor, N 5-10 -methylenetetrahydrofolate, bind to thymidylate synthase (TS) to form a covalently bound ternary complex. This binding inhibits the formation of thymidylate from 2'-deoxyuridylate. Thymidylate is the necessary precursor of thymidine triphosphate, which is essential for the synthesis of DNA, so that a deficiency of this compound can inhibit cell division.

Second, nuclear transcriptional enzymes can mistakenly incorporate FUTP in place of uridine triphosphate (UTP) during the synthesis of RNA. This metabolic error can interfere with RNA processing and protein synthesis.

📦 How Supplied / Storage and Handling 121 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 150 mg: Light pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 150. 150 mg tablets are packaged in bottles of 60 (NDC 72485-204-60). 500 mg: Dark pink coloured, capsule shaped, biconvex film coated tablet debossed with one side CAP and other side 500.

500 mg tablets are packaged in bottles of 120 (NDC 72485-205-12). Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. KEEP TIGHTLY CLOSED.

Capecitabine is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Any unused product should be disposed of in accordance with local requirements, or drug take back program.

📋 Description 142 words ▾

11 DESCRIPTION Capecitabine tablets USP are fluoropyrimidine carbamate with antineoplastic activity. It is an orally administered systemic prodrug of 5'-deoxy-5-fluorouridine (5'-DFUR) which is converted to 5- fluorouracil. The chemical name for Capecitabine, USP is 5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine and has a molecular weight of 359.35.

Capecitabine has the following structural formula: Capecitabine, USP is a white to off-white crystalline powder with an aqueous solubility of 26 mg/mL at 20ºC. Capecitabine tablets USP are supplied as capsule shaped, biconvex film coated tablets for oral administration. Each light pink-colored tablet contains 150 mg capecitabine and each dark pink-colored tablet contains 500 mg capecitabine.

The inactive ingredients in Capecitabine tablets USP include: anhydrous lactose, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, magnesium stearate and purified water. The light or dark pink film coating contains hydroxypropyl methylcellulose, talc, titanium dioxide, yellow iron oxide, and red iron oxide. Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Diarrhea Inform patients experiencing grade 2 diarrhea (an increase of 4 to 6 stools/day or nocturnal stools) or greater or experiencing severe bloody diarrhea with severe abdominal pain and fever to stop taking capecitabine tablets. Advise patients on the use of antidiarrheal treatments (e.g., loperamide) to manage diarrhea. [ see Warnings and Precautions ( 5.2 ) ] Cardiotoxicity Advise patients of the risk of cardiotoxicity and to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness [ see Warnings and Precautions ( 5.3 ) ].

Dihydropyrimidine Dehydrogenase Deficiency Advise patients to notify their healthcare provider if they have a known DPD deficiency. Advise patients if they have complete or near complete absence of DPD activity they are at an increased risk of acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by capecitabine tablets (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity) [ see Warnings and Precautions ( 5.4) ]. Dehydration and Renal Failure Instruct patients experiencing grade 2 or higher dehydration (IV fluids indicated < 24 hours) to stop taking capecitabine tablets immediately and to call their healthcare provider to correct the dehydration.

Advise patients to not restart capecitabine tablets until rehydrated and any precipitating causes have been corrected or controlled [ see Warnings and Precautions ( 5.5 ) ]. Important Administration Instructions Advise patients to swallow capecitabine tablets whole with water within 30 minutes of a meal. Advise patients and caregivers not to crush or cut capecitabine tablets.

Advise patients if they cannot swallow capecitabine tablets whole, to inform their healthcare provider [ see Dosage and Administration ( 2.1 )] . Nausea Instruct patients experiencing grade 2 nausea (food intake significantly decreased but able to eat intermittently) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider for management of nausea [ see Adverse Reactions ( 6.1 ) ]. Vomiting Instruct patients experiencing grade 2 vomiting (2 to 5 episodes in a 24-hour period) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider for management of vomiting [ see Adverse Reactions ( 6.1 ) ].

Hand-and-Foot Syndrome Instruct patients experiencing grade 2 hand-and-foot syndrome (painful erythema and swelling of the hands and/or feet and/or discomfort affecting the patients’ activities of daily living) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider. Inform patients that initiation of symptomatic treatment is recommended and hand-and-foot syndrome can lead to loss of fingerprints which could impact personal identification [ see Adverse Reactions ( 6.1 ) ].

Stomatitis Inform patients experiencing grade 2 stomatitis (painful erythema, edema or ulcers of the mouth or tongue, but able to eat) or greater to stop taking capecitabine tablets immediately and to contact their healthcare provider [ see Adverse Reactions ( 6.1 ) ]. Fever and Neutropenia Inform patients who develop a fever of 100.5°F or greater or other evidence of potential infection to contact their healthcare provider [ see Adverse Reactions ( 6.1 )]. Embryo-Fetal Toxicity Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with capecitabine and for 6 months after the last dose.

Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.6) ] , Use in Specific Populations ( 8.1 and 8.3 ) . Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ca… [Excerpted — this section continues on DailyMed.]

💬 Patient Medication Information ~3 min read ▾

Patient Information Capecitabine Tablets USP, Film Coated (KAP-e-SYE-ta-been) What is the most important information I should know about Capecitabine tablets? Capecitabine tablets can cause serious side effects, including: Capecitabine tablets can interact with blood thinner medicines, such as warfarin (COUMADIN). Taking Capecitabine tablets with these medicines can cause changes in how fast your blood clots, and can cause bleeding that can lead to death.

This can happen as soon as a few days after you start taking Capecitabine tablets, or later during treatment, and possibly even within 1 month after you stop taking Capecitabine tablets. Your risk may be higher because you have cancer, and if you are over 60 years of age. Before taking Capecitabine tablets, tell your healthcare provider if you are taking warfarin (COUMADIN) or another blood thinner medicine.

If you take warfarin (COUMADIN) or another blood thinner that is like warfarin (COUMADIN) during treatment with Capecitabine tablets, your healthcare provider should do blood tests often, to check how fast your blood clots during and after you stop treatment with Capecitabine tablets. Your healthcare provider may change your dose of the blood thinner medicine if needed. See "What are the possible side effects of Capecitabine tablets?" for more information about side effects.

What is Capecitabine tablets? Capecitabine tablets is a prescription medicine used to treat people with: cancer of the colon that has spread to lymph nodes in the area close to the colon (Dukes' C stage), after they have surgery. cancer of the colon or rectum (colorectal) that has spread to other parts of the body (metastatic). breast cancer that has spread to other parts of the body (metastatic) together with another medicine called docetaxel after treatment with certain other anticancer medicines have not worked. breast cancer that has spread to other parts of the body and has not improved after treatment with paclitaxel and certain other anti-cancer medicines, or who cannot receive any more treatment with certain anti-cancer medicines.

It is not known if Capecitabine tablets are safe and effective in children. Who should not take Capecitabine tablets? Do not take Capecitabine tablets if you: have severe kidney problems. are allergic to capecitabine, 5-fluorouracil, or any of the ingredients in Capecitabine tablets.

See the end of this leaflet for a complete list of ingredients in Capecitabine tablets. Talk to your healthcare provider before taking Capecitabine tablets if you are not sure if you have any of the conditions listed above. Before taking Capecitabine tablets, tell your healthcare provider about all your medical conditions, including if you: See "What is the most important information I should know about Capecitabine tablets?" .

Before you take Capecitabine tablets, tell your doctor if you: have had heart problems. have kidney or liver problems. have been told that you lack the enzyme DPD (dihydropyrimidine dehydrogenase) have any other medical conditions. are pregnant or plan to become pregnant. Capecitabine tablets can harm your unborn baby. Your healthcare provider should do a pregnancy test before you start treatment with capecitabine tablets.

Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with capecitabine tablets. Ø Females who are able to become pregnant should use effective birth control during treatment and for 6 months after the final dose. Talk to your healthcare provider about birth control choices that may be right for you during treatment with capecitabine tablets. Ø Males who have female partners who are able to become pregnant should use effective birth control during treatment and for 3 months after the final dose. are breastfeeding or plan to breastfeed.

It is not known if Capecitabine tablets passes into your breast milk. You and your doctor should decide if you will take Capecitabine tablets or breastfeed… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption Following oral administration of 1255 mg/m 2 BID to cancer patients, capecitabine reached peak blood levels in about 1.5 hours (T max ) with peak 5-FU levels occurring slightly later, at 2 hours. Food reduced both the rate and extent of absorption of capecitabine with mean C max and AUC 0-∞ decreased by 60% and 35%, respectively. The C max and AUC 0-∞ of 5-FU were also reduced by food by 43% and 21%, respectively.

Food delayed T max of both parent and 5-FU by 1.5 hours [see Warnings and Precautions (5) , Dosage and Administration (2) , and Drug-Food Interaction (7.2) ] . The pharmacokinetics of capecitabine and its metabolites have been evaluated in about 200 cancer patients over a dosage range of 500 to 3500 mg/m 2 /day. Over this range, the pharmacokinetics of capecitabine and its metabolite, 5'-DFCR were dose proportional and did not change over time.

The increases in the AUCs of 5'-DFUR and 5-FU, however, were greater than proportional to the increase in dose and the AUC of 5-FU was 34% higher on day 14 than on day 1. The interpatient variability in the C max and AUC of 5-FU was greater than 85%. Distribution Plasma protein binding of capecitabine and its metabolites is less than 60% and is not concentration-dependent.

Capecitabine was primarily bound to human albumin (approximately 35%). Capecitabine tablet has a low potential for pharmacokinetic interactions related to plasma protein binding. Bioactivation and Metabolism Capecitabine is extensively metabolized enzymatically to 5-FU.

In the liver, a 60 kDa carboxylesterase hydrolyzes much of the compound to 5'-deoxy-5-fluorocytidine (5'-DFCR). Cytidine deaminase, an enzyme found in most tissues, including tumors, subsequently converts 5'DFCR to 5'-DFUR. The enzyme, thymidine phosphorylase (dThdPase), then hydrolyzes 5'-DFUR to the active drug 5-FU.

Many tissues throughout the body express thymidine phosphorylase. Some human carcinomas express this enzyme in higher concentrations than surrounding normal tissues. Following oral administration of capecitabine 7 days before surgery in patients with colorectal cancer, the median ratio of 5-FU concentration in colorectal tumors to adjacent tissues was 2.9 (range from 0.9 to 8.0).

These ratios have not been evaluated in breast cancer patients or compared to 5-FU infusion. Metabolic Pathway of capecitabine to 5-FU3 The enzyme dihydropyrimidine dehydrogenase hydrogenates 5-FU, the product of capecitabine metabolism, to the much less toxic 5-fluoro-5, 6-dihydro-fluorouracil (FUH 2 ). Dihydropyrimidinase cleaves the pyrimidine ring to yield 5-fluoro-ureido-propionic acid (FUPA).

Finally, β-ureido- propionase cleaves FUPA to α-fluoro-β-alanine (FBAL) which is cleared in the urine. In vitro enzymatic studies with human liver microsomes indicated that capecitabine and its metabolites (5'-DFUR, 5'-DFCR, 5-FU, and FBAL) did not inhibit the metabolism of test substrates by cytochrome P450 isoenzymes 1A2, 2A6, 3A4, 2C19, 2D6, and 2E1. Excretion Capecitabine and its metabolites are predominantly excreted in urine; 95.5% of administered capecitabine dose is recovered in urine.

Fecal excretion is minimal (2.6%). The major metabolite excreted in urine is FBAL which represents 57% of the administered dose. About 3% of the administered dose is excreted in urine as unchanged drug.

The elimination half-life of both parent capecitabine and 5-FU was about 0.75 hour. Effect of Age, Gender, and Race on the Pharmacokinetics of Capecitabine A population analysis of pooled data from the two large controlled studies in patients with metastatic colorectal cancer (n=505) who were administered capecitabine at 1250 mg/m 2 twice a day indicated that gender (202 females and 303 males) and race (455 white/Caucasian patients, 22 black patients, and 28 patients of other race) have no influence on the pharmacokinetics of 5'-DFUR, 5-FU and FBAL.

Age has no significant influence on the pharmacokinetics of 5'-DFUR and 5-FU over the ran… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Adjuvant Colon Cancer A multicenter randomized, controlled phase 3 clinical trial in patients with Dukes' C colon cancer (X-ACT) provided data concerning the use of capecitabine for the adjuvant treatment of patients with colon cancer. The primary objective of the study was to compare disease-free survival (DFS) in patients receiving capecitabine to those receiving IV 5-FU/LV alone. In this trial, 1987 patients were randomized either to treatment with capecitabine 1250 mg/m 2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks) or IV bolus 5-FU 425 mg/m 2 and 20 mg/m 2 IV leucovorin on days 1 to 5, given as 4-week cycles for a total of 6 cycles (24 weeks).

Patients in the study were required to be between 18 and 75 years of age with histologically-confirmed Dukes' stage C colon cancer with at least one positive lymph node and to have undergone (within 8 weeks prior to randomization) complete resection of the primary tumor without macroscopic or microscopic evidence of remaining tumor. Patients were also required to have no prior cytotoxic chemotherapy or immunotherapy (except steroids), and have an ECOG performance status of 0 or 1 (KPS ≥ 70%), ANC ≥ 1.5x10 9 /L, platelets ≥ 100x10 9 /L, serum creatinine ≤

1.5 ULN, total bilirubin ≤

1.5 ULN, AST/ALT ≤

2.5ULN and CEA within normal limits at time of randomization. The baseline demographics for capecitabine and 5-FU/LV patients are shown in Table 10 . The baseline characteristics were well-balanced between arms.

Table 10 Baseline Demographics Capecitabine (n=1004) 5-FU/LV (n=983) Age (median, years) Range 62 (25-80) 63 (22-82) Gender Male (n, %) Female (n, %) 542 (54) 461 (46) 532 (54) 451 (46) ECOG PS 0 (n, %) 1 (n, %) 849 (85) 152 (15) 830 (85) 147 (15) Staging – Primary Tumor PT1 (n, %) PT2 (n, %) PT3 (n, %) PT4 (n, %) Other (n, %) 12 (1) 90 (9) 763 (76) 138 (14) 1 (0.1) 6 (0.6) 92 (9) 746 (76) 139 (14) 0 (0) Staging – Lymph Node pN1 (n, %) pN2 (n, %) Other (n, %) 695 (69) 305 (30) 4 (0.4) 694 (71) 288 (29) 1 (0.1) All patients with normal renal function or mild renal impairment began treatment at the full starting dose of 1250 mg/m 2 orally twice daily.

The starting dose was reduced in patients with moderate renal impairment (calculated creatinine clearance 30 to 50 mL/min) at baseline [see Dosage and Administration (2.4) ] . Subsequently, for all patients, doses were adjusted when needed according to toxicity. Dose management for capecitabine included dose reductions, cycle delays and treatment interruptions (see Table 11) .

Table 11 Summary of Dose Modifications in X-ACT Study Capecitabine N = 995 5-FU/LV N = 974 Median relative dose intensity (%) 93 92 Patients completing full course of treatment (%) 83 87 Patients with treatment interruption (%) 15 5 Patients with cycle delay (%) 46 29 Patients with dose reduction (%) 42 44 Patients with treatment interruption, cycle delay, or dose reduction (%) 57 52 The median follow-up at the time of the analysis was 83 months (6.9 years). The hazard ratio for DFS for capecitabine compared to 5-FU/LV was 0.88 (95% C.I.

0.77– 1.01) (see Table 12 and Figure 1 ). Because the upper 2-sided 95% confidence limit of hazard ratio was less than 1.20, capecitabine was non-inferior to 5-FU/LV. The choice of the non-inferiority margin of 1.20 corresponds to the retention of approximately 75% of the 5-FU/LV effect on DFS.

The hazard ratio for capecitabine compared to 5-FU/LV with respect to overall survival was 0.86 (95% C.I. 0.74 – 1.01). The 5-year overall survival rates were 71.4% for capecitabine and 68.4% for 5-FU/LV (see Figure 2) .

Table 12 Efficacy of Capecitabine vs 5-FU/LV in Adjuvant Treatment of Colon Cancer a All Randomized Population Capecitabine ( n = 1004 ) 5 - FU / LV ( n = 983 ) Median follow - up ( months ) 83 83 5 - year Disease - free Survival Rates (%) b 59.1

54.6Hazard Ratio (capecitabine /5-FU/LV) (95% C.I. for Hazard Ratio) p-v… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 172 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Adequate studies investigating the carcinogenic potential of capecitabine tablet have not been conducted. Capecitabine was not mutagenic in vitro to bacteria (Ames test) or mammalian cells (Chinese hamster V79/HPRT gene mutation assay). Capecitabine was clastogenic in vitro to human peripheral blood lymphocytes but not clastogenic in vivo to mouse bone marrow (micronucleus test).

Fluorouracil causes mutations in bacteria and yeast. Fluorouracil also causes chromosomal abnormalities in the mouse micronucleus test in vivo. In studies of fertility and general reproductive performance in female mice, oral capecitabine doses of 760 mg/kg/day (about 2300 mg/m 2 /day) disturbed estrus and consequently caused a decrease in fertility.

In mice that became pregnant, no fetuses survived this dose. The disturbance in estrus was reversible. In males, this dose caused degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids.

In separate pharmacokinetic studies, this dose in mice produced 5'-DFUR AUC values about 0.7 times the corresponding values in patients administered the recommended daily dose.

📚 References 8 words ▾

15 REFERENCES 1. "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

📄 Package Label / Principal Display Panel 3 words ▾

Package image description

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

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

Medicare Part D (outpatient prescription) spending for Capecitabine (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Capecitabine. 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
$750.66
Claims incl. refills
13
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$57.74
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Capecitabine 150mg (this brand).

Top reported reactions

Diarrhoea7,682
Nausea4,687
Death4,440
Disease Progression3,846
Vomiting3,790
Palmar-plantar Erythrodysaesthesia Syndrome3,745
Fatigue3,511

Age at onset

Neonate9
Infant4
Child8
Adolescent16
Adult4,696
Elderly3,192

Reporter sex

0 reports

Serious outcomes

Hospitalization19,499
Death10,181
Life-threatening2,720
Disabling821
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,317 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 Armas Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Armas Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code NONE for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 72485-0203-30 · Armas 72485-0205-12 · Armas →
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.