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Nintedanib

Nintedanib is a kinase inhibitor taken by mouth to treat idiopathic pulmonary fibrosis (IPF), other chronic fibrosing interstitial lung diseases with a progressive phenotype, and, in some products, to slow lung function decline in systemic sclerosis-associated interstitial lung disease.

Brand names OfevNintedanib esylate
Drug classes Kinase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 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 12 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 5, 2026
Nintedanib 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

Nintedanib (Ofev), on the market since about 2014 and available as a generic, is one of two main anti-scarring medicines for idiopathic pulmonary fibrosis (IPF) and other progressive scarring lung diseases, including scleroderma lung disease for some products; it blocks kinases, enzymes that signal scar tissue to form, slowing rather than reversing the damage. Side effects land mostly on the gut, with diarrhea the one most people notice, so start fluids and loperamide early as your doctor directs. The one thing to look for is liver trouble (dark urine, yellowing skin or eyes), which is why blood tests are scheduled often in the first three months.

Clinical pearls

  • Swallow capsules whole with food about 12 hours apart, never opening or chewing them; skip missed doses instead of doubling.
  • It can harm an unborn baby, so if pregnancy is possible, use highly effective birth control until three months after stopping.
  • Diarrhea or vomiting can make the pill less reliable, so add another highly effective birth control method during those spells.
  • Smoking and St. John's wort both lower nintedanib levels, so quit smoking before starting and skip that supplement.
How you get itPrescription only
Comes asCapsule
Earliest FDA record2014
Companies listing it with the FDA12
FDA label last updatedNov 20, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Nintedanib, written from its FDA label.

What Nintedanib is used for

▾

Nintedanib is used in adults for scarring lung diseases.

  • Idiopathic pulmonary fibrosis (IPF): Ofev, nintedanib esylate capsules, and nintedanib capsules.
  • Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype: Ofev, nintedanib esylate capsules, and nintedanib capsules.
  • Slowing the decline in lung function in systemic sclerosis-associated ILD (SSc-ILD): Ofev and nintedanib capsules (100 mg and 150 mg). This use is not listed for nintedanib esylate capsules.

How Nintedanib works

▾

Nintedanib is a kinase inhibitor. It blocks several growth-factor receptors, including PDGFR, FGFR and VEGFR. These send signals involved in fibrotic tissue remodeling (scar formation) in the lungs.

It attaches to the ATP-binding pocket of these kinases and shuts down their signals inside cells. It also blocks Lck, Lyn and Src kinases. How much these other actions help in lung disease is unknown.

Nintedanib dosage

▾

Nintedanib is a capsule taken by mouth twice a day, about 12 hours apart, with food. Your prescriber will set the dose, and it may be lowered if you have mild liver impairment or side effects.

  • Swallow capsules whole with liquid.
  • Do not chew, open or crush them. They taste bitter.
  • If you touch the contents, wash your hands right away.
  • If you miss a dose, skip it and take the next one at the usual time. Do not make it up.
  • Do not exceed the maximum daily amount on your label.

Dosing details from the FDA-approved label

From the Nintedanib 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.

  • Recommended dosage (all patients)
    • 150 mg taken orally twice daily administered approximately 12 hours apart
    • Maximum: Do not exceed the recommended maximum daily dosage of 300 mg
    • Taken with food; swallowed whole with liquid; do not chew, open or crush
  • Mild hepatic impairment (Child Pugh A)
    • 100 mg orally twice daily approximately 12 hours apart taken with food
    • Taken with food
  • Moderate or severe hepatic impairment
    • Treatment with nintedanib capsules is not recommended
  • Dosage modification due to adverse reactions
    • Treatment may be resumed at the full dosage (150 mg twice daily), or at the reduced dosage (100 mg twice daily), which subsequently may be increased to the full dosage
    • If 100 mg twice daily is not tolerated, discontinue treatment
    • Dose reduction or temporary interruption until the adverse reaction resolves
  • Elevated liver enzymes: AST or ALT greater than 3 times to less than 5 times the ULN without signs of liver damage
    • Interrupt treatment or reduce to 100 mg twice daily
    • Once liver enzymes return to baseline, may be reintroduced at 100 mg twice daily, then increased to 150 mg twice daily
    • Discontinue if AST or ALT greater than 3 times ULN with signs or symptoms of liver injury, or greater than 5 times ULN
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Recommended dosage: 150 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.2 ) • Recommended dosage in patients with mild hepatic impairment (Child Pugh A): 100 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.3 , 8.6 ) • Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions. ( 2.4 , 5.2 , 5.3 , 6 ) • Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. ( 2.1 , 5.2 , 5.4 ) 2.1 Testing Prior to Nintedanib Capsules Administration Conduct liver function tests in all patients and a pregnancy test in females of reproductive potential prior to initiating treatment with nintedanib capsules [see Warnings and Precautions ( 5.2 , 5.4 )]. 2.2 Recommended Dosage The recommended dosage of nintedanib capsules is 150 mg taken orally twice daily administered approximately 12 hours apart. Administration Information Nintedanib capsules should be taken with food [see Clinical Pharmacology ( 12.3 )] and swallowed whole with liquid. Nintedanib capsules should not be chewed because of a bitter taste. Nintedanib capsules should not be opened or crushed. If contact with the content of the capsule occurs, wash hands immediately and thoroughly. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known. Information for Missed Dose If a dose of nintedanib capsules is missed, the next dose should be taken at the next scheduled time. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg. 2.3 Recommended Dosage for Patients with Hepatic Impairment Mild Hepatic Impairment In patients with mild hepatic impairment (Child Pugh A), the recommended dosage of nintedanib capsules is 100 mg orally twice daily approximately 12 hours apart taken with food [see Use in Specific Populations ( 8.6 )] . Moderate or Severe Hepatic Impairment Treatment with nintedanib capsules is not recommended [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.6 )] .

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

Nintedanib side effects

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The most common side effects are mostly digestive.

Common side effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Liver enzyme elevation (found on blood tests)
  • Decreased appetite
  • Weight loss
  • Headache
  • High blood pressure

When to get medical help

  • Call your doctor if you have fatigue, loss of appetite, pain in the upper right belly, dark urine or yellowing of the skin or eyes. These can be signs of liver injury.
  • Call your doctor if diarrhea, nausea or vomiting is severe or does not improve with treatment.
  • Get emergency help for signs of a heart attack, such as chest pain.
  • Report any unusual or serious bleeding.
  • Get urgent help for severe belly pain, which can be a sign of a tear in the stomach or bowel (gastrointestinal perforation).
  • Tell your doctor if you become pregnant or think you might be.

Nintedanib warnings and precautions

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  • Liver injury: Enzyme rises and drug-induced liver injury, including fatal cases, have been reported. Most happen in the first three months. Low body weight (under 65 kg), Asian ancestry, female sex and older age may raise the risk of liver enzyme elevations.
  • Digestive effects: Diarrhea, nausea and vomiting need early treatment. Severe cases that persist may require stopping.
  • Pregnancy harm: It can cause fetal harm.
  • Heart attack and clots in arteries: Use caution if you have higher cardiovascular risk, including coronary artery disease.
  • Bleeding: It may raise bleeding risk.
  • Gastrointestinal perforation: Be careful after recent abdominal surgery, with diverticular disease, or with corticosteroids or NSAIDs.
  • Proteinuria: Nephrotic range proteinuria (large amounts of protein in the urine) has been reported.

Nintedanib interactions

▾

Some medicines change nintedanib levels or add to its risks.

  • P-gp and CYP3A4 inhibitors (such as ketoconazole, erythromycin): can raise nintedanib levels, so you may need closer monitoring.
  • P-gp and CYP3A4 inducers (such as rifampicin, carbamazepine, phenytoin, St. John's wort): can lower levels, so avoid them.
  • Full-dose blood thinners: bleeding risk may rise.
  • Oral hormonal contraceptives: vomiting or diarrhea may reduce how well they work.
  • Pirfenidone and bosentan: no change in nintedanib exposure was seen.

Interactions listed in the FDA-approved label

From the Nintedanib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • P-gp and CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): May increase exposure to nintedanib; ketoconazole increased exposure by 60%. Monitor patients closely for tolerability; management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy.
  • P-gp and CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's wort): May decrease exposure to nintedanib; rifampicin decreased exposure by 50%. Concomitant use should be avoided.
  • Anticoagulants: Nintedanib is a VEGFR inhibitor and may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary.
  • Pirfenidone: Coadministration did not alter the exposure of either agent. No dose adjustment is necessary during concomitant administration.
  • Bosentan: Coadministration did not alter the pharmacokinetics of nintedanib.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Coadministration of P-gp and CYP3A4 inhibitors may increase nintedanib exposure. Monitor patients closely for tolerability of nintedanib capsules. ( 7.1 ) 7.1 P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers Nintedanib is a substrate of P-gp and, to a minor extent, CYP3A4 [see Clinical Pharmacology ( 12.3 )] . Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Concomitant use of P-gp and CYP3A4 inhibitors (e.g., erythromycin) with nintedanib capsules may increase exposure to nintedanib [see Clinical Pharmacology ( 12.3 )] . In such cases, patients should be monitored closely for tolerability of nintedanib capsules. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with nintedanib capsules [see Dosage and Administration ( 2.4 )] . Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to nintedanib by 50%. Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John's wort) with nintedanib capsules should be avoided as these drugs may decrease exposure to nintedanib [see Clinical Pharmacology ( 12.3 )]. 7.2 Anticoagulants Nintedanib is a VEGFR inhibitor and may increase the risk of bleeding. Monitor patients on full anticoagulation therapy closely for bleeding and adjust anticoagulation treatment as necessary [see Warnings and Precautions ( 5.6 )]. 7.3 Pirfenidone In a multiple-dose study conducted to assess the pharmacokinetic effects of concomitant treatment with nintedanib and pirfenidone, the coadministration of nintedanib with pirfenidone did not alter the exposure of either agent [see Clinical Pharmacology ( 12.3 )] . Therefore, no dose adjustment is necessary during concomitant administration of nintedanib with pirfenidone.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

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 Nintedanib

▾
  • Liver disease: not recommended for moderate or severe impairment. Mild impairment needs a reduced dose.
  • Pregnancy: a pregnancy test is done first. Use highly effective contraception during treatment and for at least 3 months after.
  • Breastfeeding: not recommended.
  • Heart disease, bleeding risk, recent abdominal surgery or diverticular disease: tell your prescriber.
  • Kidney disease: no starting-dose change for mild to moderate impairment. Not studied in severe or end-stage kidney disease.
  • Smokers: smoking lowers drug levels, so you are encouraged to stop.
  • Children: safety and effectiveness have not been established.
  • Older adults: no overall differences were seen, but some may be more sensitive.

Nintedanib overdose

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In trials, people who took more than the recommended amount had side effects consistent with the known profile, and they recovered. If an overdose happens, treatment is interrupted and supportive care is given as needed.

What Nintedanib does in the body

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In a study in people with renal cell cancer, nintedanib did not lengthen the QTcF interval, a measure of the heart's electrical rhythm. This was true for a single dose and for repeated twice-daily dosing over 15 days.

How your body processes Nintedanib

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Nintedanib reaches peak blood levels about 2 to 4 hours after a dose taken with food. Only a small share is absorbed, and food raises exposure by about 20%. Its effective half-life in IPF is about 9.5 hours, and steady levels are reached within a week.

It is mainly broken down by esterase enzymes, with a small role for CYP3A4. Most of it leaves through stool and bile, and very little leaves through the kidneys.

How to store Nintedanib

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . Protect from exposure to high humidity and avoid excessive heat.

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

285

Supplements & herbs that interact with Nintedanib

285 supplements and herbal products have documented interactions with Nintedanib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 240
  • Minor · 40
Every supplement checked against Nintedanib — ranked by severity The full interaction hub: 5 major · 240 moderate · 40 minor · every one linked to its full report. Check Nintedanib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Nintedanib: pharmacist answers to common questions

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

What is nintedanib used for?

▾
It treats scarring lung diseases in adults. That includes idiopathic pulmonary fibrosis and other chronic fibrosing interstitial lung diseases that keep getting worse. Some products, such as Ofev, are also used to slow lung function decline in systemic sclerosis-associated ILD.

How should I take my capsules?

▾
Take them twice a day, about 12 hours apart, with food. Swallow them whole with liquid. Don't chew, open or crush them. If you miss a dose, just take the next one at the usual time.

What side effects should I expect?

▾
Diarrhea is the big one, and nausea, vomiting, belly pain, and less appetite are common too. Tell us early about diarrhea so we can help with fluids and medicine like loperamide. Call your doctor if it is severe or doesn't improve.

Why do I need blood tests?

▾
Nintedanib can affect your liver, mostly in the first three months. We check liver tests before you start, regularly early on, and periodically afterward. Call us if you notice dark urine, yellow skin or eyes, unusual tiredness or upper right belly pain.

Is it safe during pregnancy?

▾
No. It can harm an unborn baby. You'll need a pregnancy test first and highly effective birth control during treatment and for at least 3 months after your last dose. If vomiting or diarrhea affects your birth control pills, use another reliable method.

Do I need to avoid any other medicines or smoking?

▾
Yes, check with us before adding anything new. Avoid St. John's wort, carbamazepine and phenytoin, since they can lower nintedanib levels. Smoking also lowers levels, so try to quit. Tell us if you take blood thinners.

Is Nintedanib available over the counter?

▾
No. Nintedanib is a prescription medicine: every Nintedanib 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 Nintedanib first available?

▾
The earliest FDA record we hold for Nintedanib is from 2014: 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 Nintedanib was first used.

Who makes Nintedanib?

▾
12 companies currently list Nintedanib products in the FDA's NDC Directory, including Apotex Corp., AvKARE, Boehringer Ingelheim Pharmaceuticals, Inc.. 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 Nintedanib on HelloPharmacist

Detailed data & references for Nintedanib 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.

Nintedanib forms and strengths (how it comes)

Nintedanib is available in 1 form. 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.

Capsule

By mouth
Brands Nintedanib esylate Ofev
How this form is used
What it may be used for
  • Ofev is indicated for IPF, progressive chronic fibrosing ILDs, and SSc-ILD.
  • Nintedanib esylate capsules are indicated for IPF and progressive chronic fibrosing ILDs.
  • Nintedanib capsules (100 mg and 150 mg) are indicated for IPF, progressive chronic fibrosing ILDs, and SSc-ILD.
Important instructions
  • Ofev capsules are taken by mouth about 12 hours apart with food and swallowed whole with liquid.
  • Ofev capsules should not be chewed, opened or crushed. Wash hands right away if you touch the contents.
  • Nintedanib capsules (100 mg and 150 mg) follow the same rules: with food, swallowed whole, and not chewed, opened or crushed.
  • For a missed dose of nintedanib esylate capsules, skip it and take the next dose at the regular time.
Available strengths 2 strengths
36 FDA-listed product records ⓘ

Nintedanib on the U.S. market: products, makers and brands

How Nintedanib 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.

12 companies list 24 Nintedanib product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2014. Brand names on the directory include Ofev, Nintedanib esylate; the rest are generics.

1
Dose forms ⓘ
12
Labelers (makers, repackagers, distributors)
4
Brand names
24
FDA-listed product records ⓘ
2014
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Apotex Corp.8%
AvKARE8%
Boehringer Ingelheim Pharmaceuticals, Inc.8%
Cipla USA Inc.8%
Dr. Reddy's Laboratories Inc.8%
Epic Pharma Llc8%
Other makers50%

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

How widely Nintedanib is used (Medicaid data)

A general measure of how commonly Nintedanib 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 Nintedanib 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.

7,483
Medicaid prescriptions filled (Q1–Q4 2025)
$101.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Nintedanib prescribed? Of the 1,601 medications we measure, Nintedanib ranks #981 by Medicaid prescriptions — more than 39% of them.

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

Utilization by Nintedanib 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 150 mg oral capsule is the most-dispensed Nintedanib product — about 66% of these Medicaid prescriptions.

nintedanib 150 MG Oral Capsule Most dispensed

4,973 Medicaid prescriptions (Q1–Q4 2025) 66% of Nintedanib prescriptions shown $67.5M gross reimbursement (before rebates) ≈ $13,579 per prescription (gross)

Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1592750

nintedanib 100 MG Oral Capsule

2,510 Medicaid prescriptions (Q1–Q4 2025) 34% of Nintedanib prescriptions shown $34.2M gross reimbursement (before rebates) ≈ $13,621 per prescription (gross)

Summed across the 1 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1592742

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 Nintedanib, 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 2 of 22 listed Nintedanib NDCs with Medicaid activity.

Compare Nintedanib products

A representative set of FDA-listed product records for Nintedanib — 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 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Nintedanib NDCs →

Nintedanib 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 no Nintedanib recalls since July 2021.

✅No Nintedanib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 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) Nintedanib RxCUI 1592737 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1592741 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 1592742 150 MG RxCUI 1592750

Look up RxCUI 1592737 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.

Nintedanib brand names

Nintedanib is sold under 2 brand names in the FDA directory — Ofev, Nintedanib esylate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ofev Nintedanib esylate

Who makes Nintedanib: manufacturers and labelers

12 companies list Nintedanib products with the FDA. By number of product records, the largest are Apotex Corp., AvKARE, Boehringer Ingelheim Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Apotex Corp. 2 AvKARE 2 Boehringer Ingelheim Pharmaceuticals, Inc. 2 Cipla USA Inc. 2 Dr. Reddy's Laboratories Inc. 2 Epic Pharma Llc 2 Exelan Pharmaceuticals Inc. 2 Edenbridge Pharmaceuticals LLC. 2 Glenmark Pharmaceuticals Inc., USA 2 Golden State Medical Supply, Inc. 2 Macleods Pharmaceuticals Limited 2 Sandoz Inc 2

Nintedanib drug class (RxNorm)

Nintedanib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Other protein kinase inhibitors
How it works Protein Kinase 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 Nintedanib 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 Nov 20, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Nintedanib.
📈
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 Nintedanib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
Finished products in the current FDA directory
24
Companies listing them (makers, repackagers, distributors)
12
FDA labeler codes behind them ⓘ
12
Linked representative label ⓘ
Boehringer Ingelheim Pharmaceuticals, Inc.
Linked label effective
Nov 20, 2025
Composite sections available
23
Linked SPL Set ID
da1c9f37-779e-4682-816f-93d0faa4cfc9
Linked SPL Document ID
5c860918-0d7e-4aaf-b103-85f66e9dcdbe
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. Boehringer Ingelheim Pharmaceuticals, 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 →