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Gemcitabine

Gemcitabine is a chemotherapy medicine used to treat ovarian, breast, lung and pancreatic cancers (as an intravenous injection) and a certain type of bladder cancer (as the Inlexzo bladder system).

Brand names InfugemAvgemsiInlexzo
Drug classes Nucleic Acid Synthesis Inhibitors
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 8, 2026
🧬 Where this information comes from

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 20 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 8, 2026 🚨Recall on record
Other forms & routes:
Gemcitabine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Gemcitabine is a long-standing chemotherapy drug, used since about 1996 and available generically, that gets built into the DNA of dividing cells so they stop copying and die; it is given into a vein for ovarian, breast, non-small cell lung and pancreatic cancers, and placed in the bladder as Inlexzo for bladder cancer that BCG (an immune bladder treatment) has not controlled. By chemotherapy standards it is usually fairly manageable, though nausea, fever, rash, swelling and tiredness are common. The one thing to watch is low blood counts, so expect blood tests before each dose plus kidney and liver checks, and report fever, unusual bleeding or new breathing trouble promptly.

Clinical pearls

  • Lung problems can appear up to two weeks after the last dose, so new breathlessness still counts after treatment ends.
  • Tell your radiation team, because gemcitabine is not recommended alongside radiation or within 7 days of it.
  • A severe headache, confusion, seizure or vision loss needs urgent care, since it can signal a rare brain condition called PRES.
  • Use effective contraception during treatment and for 6 months (women) or 3 months (men) after the last dose.
How you get itPrescription only
Comes asInjection, Bladder insert
Earliest FDA record1996
Companies listing it with the FDA13
FDA label last updatedApr 27, 2026
FDA’s strongest warning (boxed)None on the label

Patient Information Guide A plain-language walkthrough of Gemcitabine, written from its FDA label.

What Gemcitabine Is Used For

▾

Gemcitabine treats several cancers, depending on the product.

  • Intravenous gemcitabine products (Avgemsi, gemcitabine injection and gemcitabine for injection): advanced ovarian cancer that relapsed at least 6 months after platinum-based therapy, used with carboplatin
  • Metastatic breast cancer, first-line after prior anthracycline-containing chemotherapy, used with paclitaxel
  • Inoperable, locally advanced or metastatic non-small cell lung cancer, used with cisplatin
  • Locally advanced or metastatic pancreatic cancer (adenocarcinoma), alone, including in people previously treated with fluorouracil
  • Inlexzo (intravesical system): adults with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors

How Gemcitabine Works

▾

Gemcitabine is a nucleoside metabolic inhibitor. Your body converts it to active forms that get built into the DNA of dividing cells.

Once it is in the DNA, the chain can add only one more building block and then stalls. This leads to programmed cell death (apoptosis) and stops cancer cells from progressing through their division cycle.

Gemcitabine Dosage

▾

Intravenous gemcitabine products are given by a healthcare professional as an infusion of about 30 minutes, on set days of repeating treatment cycles. The schedule differs by cancer type and whether it is combined with other drugs.

Inlexzo is a separate regimen. A trained provider places it in the bladder every 3 weeks at first, then less often, removing it after each 3-week period. If an Inlexzo dose is missed, it should be given as close as possible to the original schedule. Always follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Gemcitabine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Ovarian Cancer
    • 1000 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after Gemcitabine for Injection administration
    • Myelosuppression: Day 8 give 50% of full dose if ANC 1000 to 1499 or platelets 75,000 to 99,999 (x 10^6/L); hold if ANC less than 1000 or platelets less than 75,000; permanently reduce to 800 mg/m2 on Days 1 and 8 after initial severe toxicity
  • Breast Cancer
    • 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with paclitaxel 175 mg/m2 administered as a 3-hour intravenous infusion on Day 1 before Gemcitabine for Injection administration
    • Myelosuppression: Day 8 give 75% of full dose if ANC 1000 to 1199 or platelets 50,000 to 75,000; 50% of full dose if ANC 700 to 999 and platelets greater than or equal to 50,000; hold if ANC less than 700 or platelets less than 50,000
  • Non-Small Cell Lung Cancer (28-day schedule)
    • 1000 mg/m2 intravenously over 30 minutes on Days 1, 8, and 15 of each 28-day cycle, in combination with cisplatin 100 mg/m2 intravenously on Day 1 after Gemcitabine for Injection administration
    • Myelosuppression: 75% of full dose if ANC 500 to 999 or platelets 50,000 to 99,999; hold if ANC less than 500 or platelets less than 50,000
  • Non-Small Cell Lung Cancer (21-day schedule)
    • 1250 mg/m2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with cisplatin 100 mg/m2 intravenously on Day 1 after Gemcitabine for Injection administration
    • Myelosuppression: 75% of full dose if ANC 500 to 999 or platelets 50,000 to 99,999; hold if ANC less than 500 or platelets less than 50,000
  • Pancreatic Cancer
    • 1000 mg/m2 intravenously over 30 minutes
    • Weekly dosing for the first 7 weeks followed by one week rest
    • After week 8, weekly dosing on Days 1, 8, and 15 of each 28-day cycle
    • Myelosuppression: 75% of full dose if ANC 500 to 999 or platelets 50,000 to 99,999; hold if ANC less than 500 or platelets less than 50,000
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Gemcitabine Injection is for intravenous use only. Ovarian cancer: 1000 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.1 ) Breast cancer: 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.2 ) Non-small cell lung cancer:1000 mg/m 2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m 2 over 30 minutes on Days 1 and 8 of each 21-day cycle. ( 2.3 ) Pancreatic cancer: 1000 mg/m 2 over 30 minutes once weekly for the first 7 weeks, then one-week rest, then once weekly for 3 weeks of each 28-day cycle. ( 2.4 ) 2.1 Ovarian Cancer Recommended Dose and Schedule The recommended dosage of Gemcitabine Injection is 1000 mg/m 2 intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle, in combination with carboplatin AUC 4 administered intravenously on Day 1 after Gemcitabine Injection administration. Refer to carboplatin prescribing information for additional information. Dosage Modifications Recommended dosage modifications for Gemcitabine Injection for myelosuppression are described in Tables 1 and 2 [see Warnings and Precautions ( 5.2 )] . Refer to the recommended dosage modifications for non-hematologic adverse reactions [see Dosage and Administration ( 2.5) ] .

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Gemcitabine Side Effects

▾

Common effects seen with gemcitabine used alone include:

Common side effects

  • Nausea and vomiting
  • Low red blood cells (anemia)
  • Low white blood cells (neutropenia)
  • Low platelets (thrombocytopenia)
  • Raised liver enzymes (AST, ALT, alkaline phosphatase)
  • Protein or blood in the urine
  • Fever
  • Rash, shortness of breath and swelling (edema)
  • Raised liver tests

When to get medical help

  • Call your care team right away about unexplained shortness of breath or new breathing problems. Lung problems can start up to 2 weeks after the last dose.
  • Get help for signs of low blood counts, such as fever or infection, unusual bleeding or bruising, or marked tiredness.
  • Report kidney problems, including less urine, swelling, or signs of hemolytic uremic syndrome (a condition that destroys red blood cells and harms the kidneys).
  • Report signs of liver injury.
  • Seek urgent help for severe headache, seizure, confusion, vision loss or marked drowsiness. These can signal posterior reversible encephalopathy syndrome (PRES).
  • Tell your team about severe swelling or fluid leaking from blood vessels (capillary leak syndrome).
  • Seek help right away for allergic reactions such as anaphylaxis.

Gemcitabine Warnings and Precautions

▾
  • Low blood counts: checked before each dose, with doses adjusted or held as needed.
  • Lung toxicity: can be fatal and may start up to 2 weeks after the last dose. The drug is stopped for unexplained shortness of breath.
  • Kidney damage (HUS): may not be reversible. Kidney function is monitored.
  • Liver injury: including liver failure; people with liver disease or heavy alcohol use are at higher risk.
  • Capillary leak syndrome and PRES: treatment is stopped permanently if they occur.
  • Radiation: not recommended together with, or within 7 days of, radiation therapy.
  • Infusion timing: longer infusions or more frequent dosing raise toxicity.

Gemcitabine Interactions

▾

Gemcitabine is often combined with other cancer drugs, and several interactions matter.

  • Carboplatin, paclitaxel, cisplatin: combinations raise the risk of low blood counts.
  • Radiation therapy: given together or within 7 days, it can cause severe, life-threatening toxicity.
  • Other liver-toxic drugs: may add to the risk of liver injury.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before Taking Gemcitabine

▾
  • Tell your doctor if you've ever had an allergic reaction to gemcitabine.
  • Mention any kidney or liver disease, hepatitis, heavy alcohol use or cirrhosis.
  • Pregnancy: it can harm a fetus. A pregnancy test is advised first, and effective contraception is needed for 6 months (females) or 3 months (males) after the last dose.
  • Do not breastfeed during treatment and for at least one week after.
  • Not established as safe and effective in children.
  • Older adults and women may have more severe low blood counts.

Gemcitabine Overdose

▾

There is no known antidote for gemcitabine overdose. Large doses caused low blood counts, tingling or numbness (paresthesias) and severe rash. Blood counts should be monitored and supportive care given as needed.

How to Store Gemcitabine

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Store at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Gemcitabine: Pharmacist Answers to Common Questions

Quick, plain-English answers to the questions patients ask most about Gemcitabine — the kind of thing our pharmacy team would talk through with you at the counter.

What is gemcitabine used for?

▾
It's a chemotherapy medicine. The IV forms treat ovarian, breast, non-small cell lung and pancreatic cancers, often alongside other cancer drugs. A separate product, Inlexzo, is placed in the bladder for a specific kind of bladder cancer that no longer responds to BCG.

How will I get it?

▾
The IV forms are given by a healthcare professional as an infusion of about 30 minutes on set days of a treatment cycle. Inlexzo is placed in and removed from the bladder by a trained provider. Your team will set the exact schedule.

What side effects should I expect?

▾
Nausea and vomiting, low blood counts, fever, rash, swelling, shortness of breath and changes in liver or urine tests are common. Your blood is checked before each dose to catch problems early.

When should I call my care team right away?

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Call for new or unexplained shortness of breath, fever or signs of infection, unusual bleeding, severe headache, seizure, confusion, vision changes, or a drop in urine. Get emergency help for signs of a serious allergic reaction.

Is it safe in pregnancy?

▾
No. Gemcitabine can harm an unborn baby, so tell your doctor if you could be pregnant. Women should use effective contraception during treatment and for 6 months after, and men for 3 months after. Don't breastfeed during treatment and for at least a week afterward.

Can I have radiation therapy while on it?

▾
This combination isn't recommended. Given together or within 7 days of each other, radiation and gemcitabine caused severe toxicity. Make sure your oncology team coordinates the timing.

Is Gemcitabine available over the counter?

▾
No. Gemcitabine is a prescription medicine: every Gemcitabine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Gemcitabine first available?

▾
The earliest FDA record we hold for Gemcitabine is from 1996: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Gemcitabine was first used.

Who makes Gemcitabine?

▾
13 companies currently list Gemcitabine products in the FDA's NDC Directory, including Hospira, Inc., BluePoint Laboratories, Fresenius Kabi USA, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More About Gemcitabine on HelloPharmacist

Detailed Data & References for Gemcitabine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Gemcitabine Forms and Strengths (How It Comes)

Gemcitabine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Gemcitabine inactive ingredients by manufacturer.

Injection

Into a vein
Brands Avgemsi
How this form is used
What it may be used for
  • Avgemsi and Gemcitabine injection are used with carboplatin for advanced ovarian cancer that has come back at least 6 months after platinum-based treatment.
  • Avgemsi and Gemcitabine injection are used with paclitaxel as first-line treatment of metastatic breast cancer after earlier anthracycline-containing chemotherapy has failed, unless anthracyclines could not be used.
  • Avgemsi and Gemcitabine injection are used with cisplatin for non-small cell lung cancer that is inoperable, locally advanced, or metastatic.
  • Avgemsi and Gemcitabine injection are used alone as first-line treatment of locally advanced or metastatic pancreatic cancer, including in people previously treated with fluorouracil.
Important instructions
  • Avgemsi and Gemcitabine injection are given into a vein (intravenously) only.
  • Avgemsi and Gemcitabine injection are each given as an infusion over about 30 minutes.
  • Avgemsi and Gemcitabine injection are given on set days within repeating treatment cycles, and the schedule depends on the type of cancer.
  • Avgemsi and Gemcitabine injection doses may be delayed, reduced, or held based on blood counts, so your prescriber sets the exact plan.
Available strengths 10 strengths
Show 4 more strengths Show fewer strengths
85 FDA-listed product records ⓘ

Bladder insert

Into the bladder
Brands Inlexzo
How this form is used
What it may be used for
  • Inlexzo is used for adults with non-muscle invasive bladder cancer with carcinoma in situ (with or without papillary tumors) that has not responded to BCG treatment.
Important instructions
  • Inlexzo is placed into the bladder only (intravesical use) and is not given by any other route.
  • Inlexzo is inserted and removed by a trained healthcare provider, using the urinary catheter and stylet that come in the package.
  • Inlexzo is inserted about once every 3 weeks at first, then about once every 12 weeks, and it is removed after each 3-week period in the bladder.
  • Inlexzo is a hazardous drug, so special handling and disposal steps are followed during insertion and removal.
Available strengths 1 strength
1 FDA-listed product record ⓘ

Gemcitabine on the U.S. Market: Products, Makers and Brands

How Gemcitabine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

13 companies list 35 Gemcitabine product records with the FDA, mostly as injection, bladder insert; the earliest marketing or approval year on record is 1996. Brand names on the directory include Infugem, Avgemsi, Inlexzo; the rest are generics.

2
Dose forms ⓘ
13
Labelers (makers, repackagers, distributors)
4
Brand names
35
FDA-listed product records ⓘ
1996
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) · Unfinished tablet (1) — bulk drug substance and unfinished product sold to compounders and other manufacturers to finish, and multi-item kits. These aren’t counted in the dose-form total above.

Hospira, Inc.17%
BluePoint Laboratories9%
Fresenius Kabi USA, LLC9%
Hikma Pharmaceuticals USA Inc.9%
Meitheal Pharmaceuticals Inc.9%
Mylan Institutional LLC9%
Other makers40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How Widely Gemcitabine Is Used (Medicaid Data)

A general measure of how commonly Gemcitabine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Gemcitabine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

19,565
Medicaid prescriptions filled (Q1–Q4 2025)
$2.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Gemcitabine prescribed? Of the 1,601 medications we measure, Gemcitabine ranks #799 by Medicaid prescriptions — more than 50% of them.

Where Gemcitabine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Gemcitabine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 26.3 mL / 38 mg/mL injection is the most-dispensed Gemcitabine product — about 44% of these Medicaid prescriptions.

26.3 ML gemcitabine 38 MG/ML Injection Most dispensed

8,692 Medicaid prescriptions (Q1–Q4 2025) 44% of Gemcitabine prescriptions shown $781,525 gross reimbursement (before rebates) ≈ $90 per prescription (gross)

Summed across the 6 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1720960

52.6 ML gemcitabine 38 MG/ML Injection

4,164 Medicaid prescriptions (Q1–Q4 2025) 21% of Gemcitabine prescriptions shown $681,199 gross reimbursement (before rebates) ≈ $164 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1720975

5.26 ML gemcitabine 38 MG/ML Injection

3,501 Medicaid prescriptions (Q1–Q4 2025) 18% of Gemcitabine prescriptions shown $377,136 gross reimbursement (before rebates) ≈ $108 per prescription (gross)

Summed across the 4 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1720977

gemcitabine 1000 MG Injection

2,147 Medicaid prescriptions (Q1–Q4 2025) 11% of Gemcitabine prescriptions shown $422,710 gross reimbursement (before rebates) ≈ $197 per prescription (gross)

Summed across the 7 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719003

gemcitabine 200 MG Injection

675 Medicaid prescriptions (Q1–Q4 2025) 3% of Gemcitabine prescriptions shown $66,393 gross reimbursement (before rebates) ≈ $98 per prescription (gross)

Summed across the 6 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719000

gemcitabine 100 MG/ML Injectable Solution

223 Medicaid prescriptions (Q1–Q4 2025) 1% of Gemcitabine prescriptions shown $14,983 gross reimbursement (before rebates) ≈ $67 per prescription (gross)

Summed across the 3 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1998783

gemcitabine 2000 MG Injection

163 Medicaid prescriptions (Q1–Q4 2025) <1% of Gemcitabine prescriptions shown $7,741 gross reimbursement (before rebates) ≈ $47 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719005

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Gemcitabine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 32 of 74 listed Gemcitabine NDCs with Medicaid activity.

Compare Gemcitabine Products

A representative set of FDA-listed product records for Gemcitabine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 35 of 35 products — FDA National Drug Code Directory. See every product, package size and price: browse all 35 Gemcitabine NDCs →

Gemcitabine Recall History

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Gemcitabine recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jun 10, 2026 · McKesson
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
  • Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany… Lots: Lot #: CB0046, Exp. Date 06/2027 FDA record D-0714-2026 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Oct 8, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Gemcitabine RxCUI 12574 3 dose forms · 19 strengths
  1. Dose form (SCDF) Drug Implant RxCUI 2723385 In current FDA listings
    Clinical drug / strength (SCD) 225 MG RxCUI 2723386
  2. Dose form (SCDF) Injectable Solution RxCUI 1998782 In current FDA listings
    Clinical drug / strength (SCD) 38 MG/ML RxCUI 2719761 100 MG/ML RxCUI 1998783
  3. Dose form (SCDF) Injection RxCUI 1718999 In current FDA listings
    Clinical drug / strength (SCD) 5.26 ML gemcitabine 38 MG/ML RxCUI 1720977 26.3 ML gemcitabine 38 MG/ML RxCUI 1720960 52.6 ML gemcitabine 38 MG/ML RxCUI 1720975 120 ML gemcitabine 10 MG/ML RxCUI 2058858 130 ML gemcitabine 10 MG/ML RxCUI 2058912 140 ML gemcitabine 10 MG/ML RxCUI 2058866 150 ML gemcitabine 10 MG/ML RxCUI 2058880 160 ML gemcitabine 10 MG/ML RxCUI 2058882 170 ML gemcitabine 10 MG/ML RxCUI 2058890 180 ML gemcitabine 10 MG/ML RxCUI 2058892 190 ML gemcitabine 10 MG/ML RxCUI 2058894 200 MG RxCUI 1719000 200 ML gemcitabine 10 MG/ML RxCUI 2058927 220 ML gemcitabine 10 MG/ML RxCUI 2058933 1000 MG RxCUI 1719003 2000 MG RxCUI 1719005

Look up RxCUI 12574 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Gemcitabine Costs Pharmacies (NADAC Benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Feb 11, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Injection, Powder, Lyophilized, For Solution · Intravenous 1 g/25 mL $20.00 each NDC details & price history
Injection, Powder, Lyophilized, For Solution · Intravenous 1 g $20.00 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Gemcitabine Brand Names

Gemcitabine is sold under 3 brand names in the FDA directory — Infugem, Avgemsi, Inlexzo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Infugem Avgemsi Inlexzo

Who Makes Gemcitabine: Manufacturers and Labelers

13 companies list Gemcitabine products with the FDA. By number of product records, the largest are Hospira, Inc., BluePoint Laboratories, Fresenius Kabi USA, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Hospira, Inc. 6 BluePoint Laboratories 3 Fresenius Kabi USA, LLC 3 Hikma Pharmaceuticals USA Inc. 3 Meitheal Pharmaceuticals Inc. 3 Mylan Institutional LLC 3 Sagent Pharmaceuticals 3 Avyxa Pharma, LLC 2 Dr. Reddy's Laboratories Limited 2 Gland Pharma Limited 2 NorthStar Rx LLC 2 Teyro Labs Private Limited 2 Janssen Biotech, Inc 1

Gemcitabine Drug Class (RxNorm)

Gemcitabine belongs to the Nucleoside Metabolic Inhibitor class.

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

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for This Gemcitabine Page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 27, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Gemcitabine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Gemcitabine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
20
Finished products in the current FDA directory
35
Companies listing them (makers, repackagers, distributors)
13
FDA labeler codes behind them ⓘ
13
Linked representative label ⓘ
Hospira, Inc.
Linked label effective
Apr 27, 2026
Composite sections available
22
Linked SPL Set ID
e18ed1cb-7dd0-4001-bfda-17d1f4587fb8
Linked SPL Document ID
c0f06508-36d7-4325-a425-707d254d185b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Hospira, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →