FDA-filed SPL labeling · retrieved through openFDA

Gemcitabine

Gemcitabine is a chemotherapy medicine used to treat pancreatic cancer, non-small cell lung cancer, metastatic breast cancer, and advanced ovarian cancer — and, as the Inlexzo intravesical system, a specific type of bladder cancer.

Brand names InfugemAvgemsiInlexzo
Drug classes ⓘ Nucleic Acid Synthesis Inhibitors
Rx Forms 3 Routes Intravenous · Intravesical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 19 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 →

At a glance
Linked label effectiveApr 27, 2026
Clinical labels in scope ⓘ19
AvailabilityRx
Earliest approval/marketing year ⓘ1996
FDA-listed product records ⓘ131
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 17, 2026 🚨Recall on record
Other forms & routes:
Injection
⭐ Gemcitabine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Gemcitabine is a chemotherapy drug used to treat pancreatic cancer, non-small cell lung cancer, metastatic breast cancer, and advanced ovarian cancer when given by IV injection, and a specific type of bladder cancer when used as the Inlexzo intravesical system. It works by blocking cancer cells from copying their DNA, triggering them to die. It requires close medical monitoring — especially blood counts, kidney function, and liver function — throughout treatment.
How we write & review this content — our editorial policy →

📖 Gemcitabine: Patient Information Guide

A plain-language walkthrough of Gemcitabine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Gemcitabine is a chemotherapy agent approved across several products and delivery forms for the following cancers:

  • Pancreatic cancer: Gemcitabine injection (Avgemsi, Gemcitabine, gemcitabine hydrochloride) is used alone as a first-line treatment for locally advanced or metastatic pancreatic cancer, including in patients previously treated with fluorouracil.
  • Non-small cell lung cancer (NSCLC): Gemcitabine injection is used in combination with cisplatin for inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer.
  • Metastatic breast cancer: Gemcitabine injection is used in combination with paclitaxel as a first-line treatment for metastatic breast cancer after prior anthracycline-containing chemotherapy (unless anthracyclines were not an option).
  • Advanced ovarian cancer: Gemcitabine injection is used in combination with carboplatin for advanced ovarian cancer that returned at least 6 months after completing platinum-based therapy.
  • Non-muscle invasive bladder cancer (NMIBC): Inlexzo — a gemcitabine-containing intravesical system — is approved for adults with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors. This is a distinct product and delivery method and is not interchangeable with the injectable forms.
⚙️How it works▾

Gemcitabine is a nucleoside metabolic inhibitor — it mimics one of the natural building blocks of DNA and sneaks its way into the process cancer cells use to copy their genetic material. Once inside a cancer cell, it is converted into two active forms. One form blocks an enzyme called ribonucleotide reductase, which the cell needs to make DNA building blocks, starving the copying process. The other form gets directly embedded into the DNA strand itself, halting its growth almost immediately. Together, these two actions cause the cancer cell to trigger its own death — a process called apoptosis.

A unique feature of gemcitabine is self-potentiation: the first active form lowers the cell's supply of a competing natural building block (dCTP), which actually makes it easier for the second active form to get incorporated into DNA — meaning gemcitabine essentially amplifies its own effect inside the cell.

💊How it's taken▾

How gemcitabine is given depends on which product you receive and which cancer is being treated.

  • IV injection (Avgemsi, Gemcitabine, gemcitabine hydrochloride): Given intravenously by a healthcare provider, typically over 30 minutes, once weekly on specific days of a repeating cycle with planned rest days in between. The number of treatment days per cycle varies by cancer type. Giving it more often or running the infusion longer than 60 minutes significantly increases the risk of serious side effects.
  • Inlexzo (intravesical system): Inserted into the bladder by a trained healthcare provider once every 3 weeks and removed after each 3-week period. This schedule continues for up to 6 months, followed by a longer maintenance phase.

Always follow the exact schedule your care team sets. If a dose is missed with Inlexzo, it should be given as close to the original schedule as possible.

🤒Side effects — in detail▾

Gemcitabine commonly causes a range of side effects that your care team will monitor closely:

  • Nausea and vomiting
  • Low red blood cell count (anemia) — may cause fatigue and weakness
  • Low white blood cell count (neutropenia) — raises risk of serious infection
  • Low platelet count (thrombocytopenia) — raises risk of bruising and bleeding
  • Elevated liver enzymes (AST, ALT, alkaline phosphatase)
  • Protein in the urine (proteinuria)
  • Fever
  • Skin rash, swelling (edema), and shortness of breath

Serious reactions requiring immediate medical attention include: severe lung problems (interstitial pneumonitis, respiratory failure), a kidney/blood condition called hemolytic uremic syndrome (HUS), severe liver injury, capillary leak syndrome, and a brain condition called posterior reversible encephalopathy syndrome (PRES). If any of these develop, gemcitabine must be stopped permanently.

⚠️Warnings & precautions▾
  • Low blood counts (myelosuppression): This is the most common serious risk. Gemcitabine can significantly lower white blood cells, red blood cells, and platelets — especially when combined with other chemotherapy. Blood counts are checked before every dose.
  • Lung toxicity: Serious lung damage — including interstitial pneumonitis (lung inflammation), pulmonary fibrosis (scarring), and respiratory failure — can occur and may be fatal. Symptoms can appear up to 2 weeks after the last dose.
  • Kidney damage (HUS): A rare but life-threatening condition called hemolytic uremic syndrome (HUS) can cause kidney failure requiring dialysis. Kidney function is monitored before and during treatment.
  • Liver toxicity: Gemcitabine can cause severe liver injury, including liver failure. Pre-existing liver disease increases this risk.
  • PRES (brain condition): A rare condition causing headache, seizures, confusion, vision changes, and high blood pressure. Diagnosis requires an MRI.
  • Radiation interaction: Giving gemcitabine within 7 days of radiation therapy can cause life-threatening reactions, including severe inflammation of the esophagus and lungs. This combination is not recommended.
  • Fetal harm: Gemcitabine can seriously harm an unborn baby. Effective contraception is required during treatment and for several months afterward for both men and women.
🔀What it interacts with▾

The FDA label identifies one major interaction to be aware of with gemcitabine:

  • Radiation therapy: Using gemcitabine at the same time as radiation, or within 7 days of it, can cause life-threatening toxicity including severe mucositis (painful sores in the mouth, throat, or esophagus) and pneumonitis (lung inflammation). Gemcitabine is not recommended in combination with radiation therapy. Radiation recall — a skin reaction at a previously irradiated area — has also been reported in patients who received gemcitabine after prior radiation.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Known allergy to gemcitabine: Gemcitabine is contraindicated if you have had a serious hypersensitivity reaction, including anaphylaxis, to gemcitabine before.
  • Liver disease: Tell your doctor if you have hepatitis, alcoholism, liver cirrhosis, or cancer that has spread to your liver — gemcitabine can worsen existing liver problems.
  • Kidney problems: Your kidney function will be checked before and during treatment, as gemcitabine can cause or worsen kidney damage.
  • Pregnancy: Gemcitabine can cause birth defects and fetal death. Pregnancy should be ruled out before starting treatment. Women of reproductive potential must use effective contraception during treatment and for 6 months after the final dose.
  • Men planning to father children: Male patients should use effective contraception during treatment and for 3 months after the last dose. Gemcitabine may affect male fertility; it is not known if this is reversible.
  • Breastfeeding: Do not breastfeed during treatment or for at least one week after the final dose.
  • Older adults: People 65 and older — especially older women — have a higher risk of severe low blood counts and may need closer monitoring.
  • Children: Safety and effectiveness of gemcitabine for the approved adult cancer indications have not been established in pediatric patients.
🚑If you take too much▾

There is no known antidote for a gemcitabine overdose. The main effects seen with very high doses include severely low blood counts (myelosuppression), numbness or tingling (paresthesias), and severe skin rash.

If an overdose is suspected, blood counts should be closely monitored and supportive care provided as needed.

📡Pharmacodynamics — effects in the body▾

Gemcitabine targets cells that are actively dividing and copying their DNA. It blocks the cell cycle at the point where a cell transitions from preparing to divide into actually copying its DNA (the G1/S-phase boundary). By disrupting both the supply of DNA building blocks and the copying process itself, it causes cancer cells to die through apoptosis — programmed cell death. This mechanism also means it can affect healthy rapidly dividing cells, which is why it lowers blood cell counts.

🔬Pharmacokinetics — how your body processes it▾

The pharmacokinetics (how the body handles the drug) of gemcitabine were studied in over 350 patients with various solid tumors. Gemcitabine is given intravenously and is processed inside cells by enzymes called nucleoside kinases into its active forms. The length of the infusion affects how long the drug stays active in the body — a longer infusion changes the drug's half-life (the time it takes the body to clear half of it). Gemcitabine clearance is lower in women and may be affected by age, though no specific dose adjustments based on age or sex are recommended in the label.

📦How to store it▾

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 Gemcitabine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

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 cancers does gemcitabine treat? ▾
Gemcitabine is used for several different cancers depending on which form you receive. The IV injection (brands include Avgemsi and Gemcitabine) treats pancreatic cancer, non-small cell lung cancer, metastatic breast cancer, and advanced ovarian cancer — sometimes alone, sometimes paired with another chemo drug. There's also a completely separate product called Inlexzo that's placed directly into the bladder and is approved for a specific type of bladder cancer that didn't respond to BCG treatment. Your doctor will tell you exactly which form and combination is right for your situation.
What side effects should I expect, and which ones mean I need to call my doctor right away? ▾
Common side effects include nausea, vomiting, fatigue from low red blood cells, fever, and skin rash. Your care team will regularly check your blood counts because gemcitabine can lower your white blood cells, red blood cells, and platelets — which raises your risk of infection and bleeding. Call your doctor right away if you develop a fever, unusual bruising or bleeding, new shortness of breath, confusion, vision changes, seizures, or notice your urine output dropping significantly. These can be signs of serious reactions that need immediate attention.
Is gemcitabine safe to take if I'm pregnant or planning to become pregnant? ▾
No — gemcitabine can seriously harm or kill an unborn baby, so it must not be used during pregnancy. If you are a woman of childbearing age, you'll need to use reliable contraception during treatment and for 6 months after your last dose. If you are a man whose partner could become pregnant, you should use contraception during treatment and for 3 months after finishing. It may also affect male fertility, though it's not yet known if that's permanent. Do not breastfeed during treatment or for at least a week after your final dose.
Can I receive radiation therapy while on gemcitabine? ▾
This combination needs to be very carefully managed. Giving gemcitabine at the same time as radiation therapy — or within 7 days of it — can cause life-threatening reactions, including severe sores in the throat and esophagus and dangerous lung inflammation. For this reason, gemcitabine is generally not given together with radiation. If you've had radiation in the past, let your oncology team know, as a skin reaction called radiation recall can sometimes occur.
How often will I need to come in for treatment and tests? ▾
For the IV forms, you'll typically come in once a week for infusions on specific days of a repeating cycle, with planned rest periods in between. Each infusion usually takes about 30 minutes. Your blood will be drawn and checked before every single dose to make sure your counts are safe enough to proceed — your doctor may reduce or pause your dose if needed. If you're using Inlexzo for bladder cancer, your provider inserts and removes it at clinic visits every 3 weeks. Either way, expect frequent contact with your care team throughout treatment.
Are there any special concerns for older adults taking gemcitabine? ▾
Yes — older adults, especially older women, tend to have a higher risk of severe low blood counts, particularly low platelets (thrombocytopenia) and low white blood cells (neutropenia). This means your team may monitor you more closely or adjust your dose more cautiously. There are no blanket age-based dose adjustments recommended in the prescribing information, but your oncologist will personalize your plan based on how your body is responding.
Is Gemcitabine available over the counter? ▾
Gemcitabine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Gemcitabine first available? ▾
Gemcitabine has been available in the United States since at least 1996, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Gemcitabine? ▾
Gemcitabine is supplied by 32 manufacturers listed in the FDA NDC Directory, including Hospira, Inc., Sun Pharmaceutical Industries, Inc., Mylan Institutional LLC.

💬 Answers drafted from Gemcitabine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

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💊 How Gemcitabine comes

Gemcitabine is available in 3 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.

Injection

Into a vein
Brands Avgemsi Infugem
How this form is used
What it may be used for
  • Avgemsi, Gemcitabine, and gemcitabine hydrochloride injections are used with carboplatin to treat advanced ovarian cancer that relapsed at least 6 months after platinum-based therapy
  • Avgemsi, Gemcitabine, and gemcitabine hydrochloride injections are used with paclitaxel as a first-line treatment for metastatic breast cancer after prior anthracycline chemotherapy
  • Avgemsi, Gemcitabine, and gemcitabine hydrochloride injections are used with cisplatin for inoperable, locally advanced, or metastatic non-small cell lung cancer
  • Avgemsi, Gemcitabine, and gemcitabine hydrochloride injections are used alone as first-line treatment for locally advanced or metastatic pancreatic cancer, including for patients previously treated with fluorouracil
Important instructions
  • Avgemsi, Gemcitabine, and gemcitabine hydrochloride are given intravenously (into a vein) by a healthcare provider — not self-administered
  • Infusions are typically given over 30 minutes, once weekly on specific days of a treatment cycle, with rest periods in between — extending the infusion beyond 60 minutes or dosing more frequently increases the risk of serious side effects
  • Blood counts must be checked before each dose; your doctor may reduce or delay your dose based on those results
  • Women of reproductive potential should use effective contraception during treatment and for 6 months after the last dose; men should use contraception for 3 months after the last dose
Available strengths 11 strengths
10 mg/mL 38 mg/mL 100 mg/mL 200 mg 200 mg/5 mL 200 mg/5.26 mL
Show 5 more strengths Show fewer strengths
1 g 1 g/25 mL 1 g/26.3 mL 2 g/50 mL 2 g/52.6 mL
111 FDA-listed product records ⓘ

Skin patch

Intravesical
Brands Inlexzo
How this form is used
What it may be used for
  • Inlexzo is indicated for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors
Important instructions
  • Inlexzo is inserted directly into the bladder by a trained healthcare provider using a co-packaged urinary catheter and stylet — it is not self-administered
  • Inlexzo is inserted once every 3 weeks for up to 6 months (8 doses), then once every 12 weeks for up to 18 additional months (6 doses), or until the cancer progresses or side effects become unacceptable
  • Inlexzo must be removed by a healthcare provider after each 3-week indwelling period
  • If a dose is missed, it should be given as close as possible to the original schedule
Available strengths 1 strength
225 mg
1 FDA-listed product record ⓘ

Tablet

By mouth
Available strengths 1 strength
21.36 mg
1 FDA-listed product record ⓘ

📊 Gemcitabine across the U.S. market

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.

3
Dose forms ⓘ
32
Manufacturers
5
Brand names
131
FDA-listed product records ⓘ
1996
First marketed ⓘ

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 (18) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Hospira, Inc.18%
Sun Pharmaceutical Industries, Inc.8%
Mylan Institutional LLC7%
Fresenius Kabi USA, LLC7%
Accord Healthcare Inc.5%
BluePoint Laboratories5%
Other makers49%

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

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 1,596 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
Total prescriptions — #799 of 1,596
#794 Revefenacin Oral Inhal... 20,174 Rx #795 Raloxifene 20,163 Rx #796 Oxymetazoline 20,124 Rx #797 Budesonide Nasal Spray 20,113 Rx #798 Efinaconazole Topical 19,808 Rx #799 Gemcitabine Injection 19,565 Rx #800 Gemcitabine 19,565 Rx #801 Benazepril and Hydroch... 19,477 Rx #802 Relugolix, Estradiol,... 19,242 Rx #803 Romiplostim Injection 19,119 Rx #804 Diflunisal 18,884 Rx

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 131 of 131 products — FDA National Drug Code Directory. See every product, package size and price: browse all 131 Gemcitabine NDCs →

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 No current FDA listing
    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.

🏷️ Sold under these brand names

Infugem Avgemsi Inlexzo

🏭 Manufacturers & labelers

Hospira, Inc. 24 Sun Pharmaceutical Industries, Inc. 11 Mylan Institutional LLC 9 Fresenius Kabi USA, LLC 9 Accord Healthcare Inc. 7 BluePoint Laboratories 7 Sagent Pharmaceuticals 7 Meitheal Pharmaceuticals Inc. 7 Hikma Pharmaceuticals USA Inc. 5 Avyxa Pharma, LLC 4 Dr. Reddy's Laboratories Limited 4 NorthStar Rx LLC 4 Gland Pharma Limited 4 Armas Pharmaceuticals Inc. 3 Ingenus Pharmaceuticals, LLC 3 Teyro Labs Private Limited 2 Jiangsu Hansoh Pharmaceutical Group Co., Ltd. 2 Athenex Pharmaceutical Division, LLC. 2 Shilpa Pharma Lifesciences Limited 2 Emcure Pharmaceuticals Limited 2 ScinoPharm Taiwan Ltd. 2 Dr.Reddys Laboratories Limited 1 Valary Lab Private Limited 1 Sicor de Mexico S.A. de C.V 1

…and 8 more on the FDA NDC directory.

RxNorm drug class

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.

🔬 Where this comes from

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
19
NDC products indexed
131
Distinct labelers/manufacturers represented
32
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 19 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Hospira, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.