Home › NDC Lookup › Ingredients › Fluorouracil › 46708-0751-50
Fluorouracil 50 mg/mL Injection, Solution — NDC 46708-0751-50 package photo

Fluorouracil 50 mg/mL Injection, Solution

by Alembic Pharmaceuticals Limited · 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-751-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE
NDC 46708-0751-50
🏷️ FDA NDC (as labeled) 46708-751-50 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 46708-751-50
Product NDC 46708-751
11-digit billing NDC 46708075150
RxCUI 239177
UNII U3P01618RT
Application # ANDA217295
SPL Set ID d10f12a2-7b38-4351-93df-1e8444d2a9e4
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 2023-03-03
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance FLUOROURACIL
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 46708-751-50 — 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 → 46708-0751-50. 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.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA217295 (ANDA)
Labeler code46708
First marketedMar 2023
Product typeHuman Prescription Drug
Portfolio502 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

Fluorouracil is generally used in combination with other medications to treat colon cancer or rectal cancer (cancer that begins in the large intestine) that has gotten worse or spread to other parts of the body. Fluorouracil is used in combination with other medications to treat certain types of breast cancer after surgery to remove the tumor or radiation therapy. Fluorouracil is also used to treat cancer of the pancreas and stomach cancer. Fluorouracil is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in your body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, it is actually expected and means the medication is working. When you apply fluorouracil topically to treat actinic keratoses or superficial skin cancer, the treated area typi...
  • Why does my skin look so bad while using the cream — is that supposed to happen?
  • DPD (dihydropyrimidine dehydrogenase) is the enzyme your body uses to break down most of the fluorouracil you receive. If you're missing this enzyme — either partially or completel...
  • What is the DPD deficiency test, and do I really need it before starting?
📖 Read our full Fluorouracil guide →
2
Nutrient depletion considerations

Fluorouracil may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Fluorouracil 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.

🧪 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 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 mLPer 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
Fluorouracil 50 mg/mL 16729-0276-11 Accord 1 vial — — FDA listed —
fluorouracil 50 mg/mL 25021-0215-98 Sagent 1 bottle — AP FDA listed —
Fluorouracil 50 mg/mLthis 46708-0751-50 Alembic 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 46708-0779-31 Alembic 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 55150-0498-01 Eugia 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 55150-0499-01 Eugia 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 62332-0751-50 Alembic 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 62332-0779-31 Alembic 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 63323-0117-59 Fresenius 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 68001-0525-27 BluePoint 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 68001-0627-27 BluePoint 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 68001-0628-32 BluePoint 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 68083-0292-01 Gland 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 68083-0293-01 Gland 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 70700-0188-22 Xiromed 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 70700-0189-22 Xiromed 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 71288-0154-76 Meitheal 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 71288-0170-75 Meitheal 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 68083-0269-10 Gland 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 55150-0497-10 Eugia 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 70700-0186-23 Xiromed 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 70700-0187-23 Xiromed 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 55150-0496-10 Eugia 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 68001-0524-30 BluePoint 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 84549-0117-10 ProPharma 10 ml — AP FDA listed —
Fluorouracil 50 mg/mL 68083-0270-10 Gland 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 23155-0972-41 Heritage 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 23155-0975-31 Heritage 1 vial — AP FDA listed —
Fluorouracil 50 mg/mL 23155-0973-41 Heritage 10 vials — AP FDA listed —
Fluorouracil 50 mg/mL 23155-0974-31 Heritage 1 vial — AP 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

🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Fluorouracil — the program that covers self-administered drugs. 13 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 Fluorouracil. 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
$13.28M
Claims incl. refills
215.6K
Beneficiaries
203.3K
Spend / beneficiary
$65.33
Spend / claim
$61.59
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 Fluorouracil — the ingredient across all brands.

Top reported reactions

Diarrhoea6,992
Neutropenia5,174
Nausea5,001
Vomiting3,997
Neuropathy Peripheral3,379
Disease Progression3,256
Fatigue3,227

Age at onset

Neonate55
Infant47
Child45
Adolescent37
Adult8,160
Elderly7,286

Reporter sex

0 reports
Male · 54%
Female · 44%
Unknown · 1%

Serious outcomes

Death10,859
Disabling1,385
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,756 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46708-0751-50 You're viewing this 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-751-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2023-03-03 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 46708-751-50, 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: 46708-0751-50, written without dashes as 46708075150. 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 46708-0751-50, the first segment (46708) is the labeler code FDA assigned to Alembic Pharmaceuticals Limited; the middle segment (0751) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (50) 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 Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 69 words ▾

1 INDICATIONS AND USAGE Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with • Adenocarcinoma of the Colon and Rectum ( 1.1 ) • Adenocarcinoma of the Breast ( 1.2 ) • Gastric Adenocarcinoma ( 1.3 ) • Pancreatic Adenocarcinoma ( 1.4 )

1.1Adenocarcinoma of the Colon and Rectum .

1.2Adenocarcinoma of the Breast .

1.3Gastric Adenocarcinoma .

1.4Pancreatic Adenocarcinoma .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Fluorouracil is recommended for administration either as an intravenous bolus or as an intravenous infusion. ( 2.1 ) • See Full Prescribing Information for dose individualization (2.1) and dose modifications due to adverse reactions ( 2.6 ) • See Full Prescribing Information for recommended doses of Fluorouracil for adenocarcinoma of the colon and rectum ( 2.2 ) and for recommended doses of Fluorouracil as a component of a chemotherapy regimen for adenocarcinoma of the breast ( 2.3 ), gastric adenocarcinoma ( 2.4 ), pancreatic adenocarcinoma ( 2.5 ) • Pharmacy Bulk Package: Prepare doses for more than one patient in a Pharmacy Admixture Service under appropriate conditions for cytotoxic drugs.

Do not inject entire contents of vial directly into patients. Use within 4 hours of puncture ( 2.7 , 2.8 )

2.1General Dosage Information Fluorouracil is recommended for administration either as an intravenous bolus or as an intravenous infusion. Do not inject the entire contents of the vial directly into patients. Individualize the dose and dosing schedule of Fluorouracil based on tumor type, the specific regimen administered, disease state, response to treatment, and patient risk factors.

2.2Recommended Dosage for Adenocarcinoma of the Colon and Rectum The recommended dose of Fluorouracil, administered in an infusional regimen in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan, is 400 mg/m 2 by intravenous bolus on Day 1, followed by 2400 mg/m 2 to 3000 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. The recommended dose of Fluorouracil, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles.

2.3Recommended Dosage for Adenocarcinoma of the Breast The recommended dose of Fluorouracil, administered as a component of a cyclophosphamide-based multidrug regimen, is 500 mg/m 2 or 600 mg/m 2 intravenously on Days 1 and 8 every 28 days for 6 cycles.

2.4Recommended Dosage for Gastric Adenocarcinoma The recommended dose of Fluorouracil, administered as a component of a platinum-containing multidrug chemotherapy regimen, is 200 mg/m 2 to 1000 mg/m 2 intravenously as a continuous infusion over 24 hours. The frequency of dosing in each cycle and the length of each cycle will depend on the dose of Fluorouracil and the specific regimen administered.

2.5Recommended Dosage for Pancreatic Adenocarcinoma The recommended dose of Fluorouracil, administered as an infusional regimen in combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin, is 400 mg/m 2 intravenous bolus on Day 1, followed by 2400 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks.

2.6Dose Modifications Withhold Fluorouracil for any of the following: • Development of angina, myocardial infarction/ischemia, arrhythmia, or heart failure in patients with no history of coronary artery disease or myocardial dysfunction [see Warnings and Precautions (5.2)] • Hyperammonemic encephalopathy [see Warnings and Precautions (5.3)] • Acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances [see Warnings and Precautions (5.4)] • Grade 3 or 4 diarrhea [see Warnings and Precautions (5.5)] • Grade 2 or 3 palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6)] • Grade 3 or 4 mucositis [see Warnings and Precautions (5.8)] • Grade 4 myelosuppression [see Warnings and Precautions (5.7)] Upon resolution or improvement to Grade 1 diarrhea, mucositis, myelosuppression, or palmar-plantar erythrodysesthesia, resume Fluorouracil administration at a reduced dose.

There is no recommended dose for resumption of Fluorouracil administration following development of any of the following adverse reactions: • Cardiac toxicity • Hyperammonemic encephalopathy • Acute cerebel…

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Fluorouracil injection, USP is supplied as a pharmacy bulk package as a vial containing 2.5 g/50 mL (50 mg/mL) Fluorouracil. Injection: 2.5 g in a 50 mL vial in a pharmacy bulk package

⛔ Contraindications 4 words ▾

4 CONTRAINDICATIONS None. None.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Increased Risk of Serious or Fatal Adverse Reactions in Patients with Low or Absent Dipyrimidine Dehydrogenase Activity: Withhold or permanently discontinue Fluorouracil in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of dipyrimidine dehydrogenase (DPD) activity. No Fluorouracil dose has been proven safe in patients with absent DPD activity. ( 5.1 ) • Cardiotoxicity: Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure.

Withhold Fluorouracil for cardiac toxicity. ( 5.2 ) • Hyperammonemic Encephalopathy: Altered mental status, confusion, disorientation, coma, or ataxia with elevated serum ammonia level can occur within 72 hours of initiation of Fluorouracil. Withhold Fluorouracil and initiate ammonia-lowering therapy.

( 5.3 ) • Neurologic Toxicity: Fluorouracil can cause acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances. Withhold Fluorouracil for neurologic toxicity. ( 5.4 ) • Diarrhea: Fluorouracil can cause severe diarrhea.

Withhold Fluorouracil for severe diarrhea until resolved. ( 5.5 ) • Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome): Fluorouracil can cause hand-foot syndrome. If severe, discontinue Fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose.

( 5.6 ) • Myelosuppression: Fluorouracil can cause severe and fatal myelosuppression. Withhold Fluorouracil until severe myelosuppression resolves, then resume at a reduced dose. ( 5.7 ) • Mucositis: Fluorouracil can cause severe mucositis.

Discontinue Fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose. ( 5.8 ) • Increased Risk of Elevated INR with Warfarin: Concurrent administration with warfarin can result in clinically significant increases in coagulation parameters: Closely monitor INR and prothrombin time.( 5.9 ) • Embryofetal Toxicity: Fluorouracil can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus.

( 5.10 , 8.1 , 8.6 )

5.1Increased Risk of Serious or Fatal Adverse Reactions in Patients with Low or Absent Dipyrimidine Dehydrogenase (DPD) Activity Based on postmarketing reports, patients with certain homozygous or certain compound heterozygous mutations in the DPD gene that result in complete or near complete absence of DPD activity are at increased risk for acute early-onset of toxicity and severe, life-threatening, or fatal adverse reactions caused by Fluorouracil (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Patients with partial DPD activity may also have increased risk of severe, life-threatening, or fatal adverse reactions caused by Fluorouracil.

Withhold or permanently discontinue Fluorouracil based on clinical assessment of the onset, duration and severity of the observed toxicities in patients with evidence of acute early-onset or unusually severe toxicity, which may indicate near complete or total absence of DPD activity. No Fluorouracil dose has been proven safe for patients with complete absence of DPD activity. There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by any specific test.

5.2Cardiotoxicity Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure, based on postmarketing reports. Reported risk factors for cardiotoxicity are administration by continuous infusion rather than intravenous bolus and presence of coronary artery disease. Withhold Fluorouracil for cardiotoxicity.

The risks of resumption of Fluorouracil in patients with cardiotoxicity that has resolved have not been established.

5.3Hyperammonemic Encephalopathy Fluorouracil can cause hyperammonemic encephalopathy in the absence of liver disease or other identifiable cause, based on postmarketing reports. Signs or symptoms of hyper…

🤒 Adverse Reactions ~1 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Increased risk of serious or fatal adverse reactions in patients with low or absent dipyrimidine dehydrogenase activity [see Warnings and Precautions (5.1)] • Cardiotoxicity [see Warnings and Precautions (5.2)] • Hyperammonemic encephalopathy [see Warnings and Precautions (5.3)] • Neurologic toxicity [see Warnings and Precautions (5.4)] • Diarrhea [see Warnings and Precautions (5.5)] • Palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6)] • Myelosuppression [see Warnings and Precautions (5.7)] • Mucositis [see Warnings and Precautions (5.8)] • Increased risk of elevated INR when administrated with warfarin [see Warnings and Precautions (5.9)] To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of Fluorouracil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hematologic: pancytopenia [see Warnings and Precautions (5.7)] Gastrointestinal: gastrointestinal ulceration, nausea, vomiting Allergic Reactions: anaphylaxis and generalized allergic reactions Neurologic: nystagmus, headache Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia Psychiatric: euphoria Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails)

🔄 Drug Interactions 75 words ▾

7 DRUG INTERACTIONS

7.1Anticoagulants and CYP 2C9 Substrates Elevated coagulation times have been reported in patients taking Fluorouracil concomitantly with warfarin. While pharmacokinetic data are not available to assess the effect of Fluorouracil administration on warfarin pharmacokinetics, the elevation of coagulation times that occurs with the Fluorouracil prodrug capecitabine is accompanied by an increase in warfarin concentrations. Thus, the interaction may be due to inhibition of cytochrome P450 2C9 by Fluorouracil or its metabolites.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Nursing Mothers: Discontinue drug or discontinue nursing. ( 8.3 ) • Females and Males of Reproductive Potential: Provide pregnancy planning and prevention counseling. ( 5.10 , 8.1 , 8.6 )

8.1Pregnancy Pregnancy Category D Risk Summary There are no adequate and well-controlled studies with Fluorouracil in pregnant women. Based on its mechanism of action, Fluorouracil can cause fetal harm when administered to a pregnant woman. Administration of Fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity.

Malformations included cleft palate and skeletal defects. In monkeys, maternal doses of Fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see Clinical Pharmacology (12.1)].

Animal Data Malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when Fluorouracil was administered by intraperitoneal injection to mice at doses at or above 10 mg/kg (approximately 0.06 times a human dose of 12 mg/kg on a mg/m 2 basis) for 4 days during the period of organogenesis. Similar results were observed in hamsters administered Fluorouracil intramuscularly at doses lower than those administered in commonly used clinical treatment regimens. In rats, administration of Fluorouracil by intraperitoneal injection at doses greater than 15 mg/kg (approximately 0.2 times a human dose of 12 mg/kg on a mg/m 2 basis) for a single day during organogenesis resulted in delays in growth and malformations including micro-anophthalmos.

In monkeys, administration of Fluorouracil during organogenesis at doses approximately equal to a human dose of 12 mg/kg on a mg/m 2 basis resulted in abortion; at a 50% lower dose, resorptions and decreased fetal body weights were reported.

8.3Nursing Mothers It is not known whether Fluorouracil or its metabolites are present in human milk. Because many drugs are present in human milk and because of the potential for serious adverse reactions in nursing infants from Fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use Reported clinical experience has not identified differences in safety or effectiveness between the elderly and younger patients.

8.6Females and Males of Reproductive Potential Contraception Females Based on its mechanism of action, Fluorouracil can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Fluorouracil and for up to 3 months following cessation of therapy [see Use in Specific Populations (8.1)]. Males Fluorouracil may damage spermatozoa.

Advise males with female partners of reproductive potential to use effective contraception during and for 3 months following cessation of therapy with Fluorouracil [see Nonclinical Toxicology (13.1)]. Infertility Females Advise females of reproductive potential that, based on animal data, fertility may be impaired while receiving Fluorouracil [see Nonclinical Toxicology (13.1)]. Males Advise males of reproductive potential that, based on animal data, fertility may be impaired while receiving Fluorouracil [see Nonclinical Toxicology (13.1)].

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Category D Risk Summary There are no adequate and well-controlled studies with Fluorouracil in pregnant women. Based on its mechanism of action, Fluorouracil can cause fetal harm when administered to a pregnant woman. Administration of Fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity.

Malformations included cleft palate and skeletal defects. In monkeys, maternal doses of Fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see Clinical Pharmacology (12.1)].

Animal Data Malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when Fluorouracil was administered by intraperitoneal injection to mice at doses at or above 10 mg/kg (approximately 0.06 times a human dose of 12 mg/kg on a mg/m 2 basis) for 4 days during the period of organogenesis. Similar results were observed in hamsters administered Fluorouracil intramuscularly at doses lower than those administered in commonly used clinical treatment regimens. In rats, administration of Fluorouracil by intraperitoneal injection at doses greater than 15 mg/kg (approximately 0.2 times a human dose of 12 mg/kg on a mg/m 2 basis) for a single day during organogenesis resulted in delays in growth and malformations including micro-anophthalmos.

In monkeys, administration of Fluorouracil during organogenesis at doses approximately equal to a human dose of 12 mg/kg on a mg/m 2 basis resulted in abortion; at a 50% lower dose, resorptions and decreased fetal body weights were reported.

🧒 Pediatric Use 14 words ▾

8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 20 words ▾

8.5Geriatric Use Reported clinical experience has not identified differences in safety or effectiveness between the elderly and younger patients.

🆘 Overdosage 19 words ▾

10 OVERDOSAGE Administer uridine triacetate within 96 hours following the end of Fluorouracil infusion for management of Fluorouracil overdose.

🧬 Clinical Pharmacology 183 words ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fluorouracil is a nucleoside metabolic inhibitor that interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA); these affect rapidly growing cells and may lead to cell death. Fluorouracil is converted to three main active metabolites: 5-fluoro-2′- deoxyuridine-5′-monophosphate (FdUMP), 5-fluorouridine-5′-triphosphate (FUTP) and 5-fluoro-2′-deoxyuridine-5′-triphosphate (FdUTP). These metabolites have several effects including the inhibition of thymidylate synthase by FdUMP, incorporation of FUTP into RNA and incorporation of FdUTP into DNA.

12.3Pharmacokinetics Distribution Following bolus intravenous injection, Fluorouracil distributes throughout the body including the intestinal mucosa, bone marrow, liver, cerebrospinal fluid and brain tissue. Elimination Following bolus intravenous injection, 5 – 20 % of the parent drug is excreted unchanged in the urine in six hours. The remaining percentage of the administered dose is metabolized, primarily in the liver.

The metabolites of Fluorouracil (e.g., urea and α-fluoro-ß-alanine) are excreted in the urine over 3 to 4 hours. Following bolus intravenous injection of Fluorouracil, as a single agent, the elimination half-life increased with dose from 8 to 20 minutes.

🧬 Mechanism of Action 82 words ▾

12.1Mechanism of Action Fluorouracil is a nucleoside metabolic inhibitor that interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA); these affect rapidly growing cells and may lead to cell death. Fluorouracil is converted to three main active metabolites: 5-fluoro-2′- deoxyuridine-5′-monophosphate (FdUMP), 5-fluorouridine-5′-triphosphate (FUTP) and 5-fluoro-2′-deoxyuridine-5′-triphosphate (FdUTP). These metabolites have several effects including the inhibition of thymidylate synthase by FdUMP, incorporation of FUTP into RNA and incorporation of FdUTP into DNA.

📦 How Supplied / Storage and Handling 105 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Fluorouracil injection, USP is a clear colorless to yellow solution, aqueous, injectable solution, and is supplied in a pharmacy bulk package as follows: NDC Fluorouracil Injection, USP (50 mg per mL) Package Factor 46708-751-50 2.5 g/50 mL Pharmacy Bulk Vial 1 vial per carton

16.2Storage Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. DO NOT FREEZE. Protect from light. Retain in carton until time of use. Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15)].

📋 Description 91 words ▾

11 DESCRIPTION Fluorouracil injection, USP a nucleoside metabolic inhibitor, is a clear colorless to yellow solution, aqueous, sterile, nonpyrogenic injectable solution available in a pharmacy bulk package, a sterile preparation that contains doses for multiple patients for intravenous administration. Each mL contains 50 mg Fluorouracil in water for injection, USP. The pH is adjusted to approximately 9.2 with sodium hydroxide.

Chemically, Fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1 H ,3 H )-pyrimidinedione. Its structural formula is: Molecular formula: C 4 H 3 FN 2 O 2 Molecular weight: 130.08 g/mole fluorouracil-structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION 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 severe and life-threatening mucositis, diarrhea, neutropenia and neurotoxicity [see Warnings and Precautions (5.1)]. • Patients of the risk of cardiotoxicity. Advise patients 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 (5.2)]. • Patients to immediately contact their healthcare provider or go to an emergency room for new onset of confusion, disorientation, or otherwise altered mental status; difficulty with balance or coordination; or visual disturbances [see Warnings and Precautions (5.3, 5.4)]. • Patients to contact their healthcare provider for severe diarrhea or for painful mouth sores with decreased oral intake of food or fluids [see Warnings and Precautions (5.5, 5.8)]. • Patients to contact their healthcare provider for tingling or burning, redness, flaking, swelling, blisters, or sores on the palms of their hands or soles of their feet [see Warnings and Precautions (5.6)]. • Patients of the importance of keeping appointments for blood tests.

Instruct patients to monitor their temperature on a daily basis and to immediately contact their healthcare provider for fever or other signs of infection [see Warnings and Precautions (5.7)]. • Patients to notify their healthcare provider of all drugs they are taking, including warfarin or other coumarin-derivative anticoagulants. Advise patients of the importance of keeping appointments for blood tests [see Warnings and Precautions (5.9)]. • Females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with Fluorouracil and for up to 3 months after the last dose of Fluorouracil.

Instruct female patients to contact their healthcare provider if they become pregnant, if pregnancy occurs during Fluorouracil treatment or during the 3 months following the last dose [see Warnings and Precautions (5.10), Use in Specific Populations (8.1 and 8.6), and Nonclinical Toxicology (13.1)]. • Females and males of reproductive potential may have impaired fertility while receiving Fluorouracil, based on animal data [see Use in Specific Populations (8.6) and Nonclinical Toxicology (13.1)]. • Nursing mothers to discontinue nursing [see Use in Specific Populations (8.3)].

Manufactured by: Alembic Pharmaceuticals Limited, Panelav – 389 350, Gujarat, India. Issued: 05/2023

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 46708-0750-05 · Alembic 46708-0755-30 · Alembic →
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.