Nintedanib 100 mg/1
Nintedanib · CAPSULE · Dr. Reddy's Laboratories Inc.
Nintedanib is a capsule containing nintedanib at 100 mg/1, taken oral. Manufactured by Dr. Reddy's Laboratories Inc..
Key Facts
- Brand Name
- Nintedanib
- Generic Name
- Nintedanib
- NDC Code (Product)
43598-148- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA219283
- Marketing Start
- 04/02/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Nintedanib Capsules is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib Capsules is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib Capsules is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies (14.2) ].
Dosage & Administration
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 beca…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
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…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Elevated Liver Enzymes and Drug-Induced Liver Injury [see Warnings and Precautions (5.2) ] Gastrointestinal Disorders [see Warnings and Precautions (5.3) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.4) ] Arterial Thromboembolic Events [see Warnings and Precautions (5.5) ] Risk of Bleeding [see Warnings and Precautions (5.6) ] Gastrointestinal Perforation [see Warnings and Precautions (5.7) ] Nephrotic Range Proteinuria [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC., DBA Dexcel Pharma USA, at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of…
Frequently Asked Questions
What is Nintedanib used for?
Nintedanib contains Nintedanib. It is a capsule taken oral. Consult your doctor for specific uses.
Is Nintedanib a controlled substance?
Nintedanib is not classified as a controlled substance by the DEA.
What is the generic name for Nintedanib?
The generic name for Nintedanib is Nintedanib. There are 5 other brand versions of Nintedanib.
What is the NDC code for Nintedanib 100 mg/1?
The NDC (National Drug Code) for Nintedanib 100 mg/1 is 43598-148, listed by Dr. Reddy's Laboratories Inc..