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Erlotinib

Erlotinib is a kinase inhibitor (prescription), made by 6 manufacturers.

Type
Prescription
Drug class
Kinase Inhibitor
Route
Oral
Manufacturers
6

Drug facts

Name
Erlotinib
Active ingredients
Erlotinib, Erlotinib Hydrochloride
Drug class
Kinase Inhibitor
How it works
Protein Kinase Inhibitors
Dosage forms
Tablet, Tablet, film coated
Label holder
Zydus Lifesciences Limited
FDA application
ANDA213065
Label updated
11/28/2024

The FDA label text for this product is not available yet. See the full label on DailyMed using the link below.

Forms and strengths

From the FDA NDC Directory · 15 product codes

Dosage formStrengthRouteNDCs
Tablet25 mgoral1
Tablet100 mgoral1
Tablet150 mgoral1
Tablet, film coated25 mgoral4
Tablet, film coated100 mgoral4
Tablet, film coated150 mgoral4

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 9,631 reports that list erlotinib, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Death2,898
  • Rash1,073
  • Diarrhea1,012
  • Off label use799
  • Malignant neoplasm progression767
  • Fatigue582
  • Nausea541
  • Drug resistance466
  • Vomiting451
  • Disease progression450

To report a side effect, use FDA MedWatch.

Manufacturers and labels

6 FDA labels

  • Zydus Lifesciences LimitedShown hereANDA213065 · Label 11/28/2024 · NDC 70771-1521, 70771-1522, 70771-1523Full label
  • Aurobindo Pharma LimitedANDA216342 · Label 06/06/2022 · NDC 59651-530, 59651-531, 59651-532Full label
  • Camber Pharmaceuticals, Inc.ANDA209267 · Label 06/26/2024 · NDC 31722-263, 31722-264, 31722-265Full label
  • Sun Pharmaceutical Industries, Inc.ANDA210300 · Label 11/06/2019 · NDC 63304-095, 63304-096, 63304-135Full label
  • Teva Pharmaceuticals USA, Inc.ANDA091059 · Label 03/17/2021 · NDC 0093-7662, 0093-7663, 0093-7664Full label
  • Zydus Pharmaceuticals USA Inc.ANDA213065 · Label 10/05/2023 · NDC 68382-913, 68382-914, 68382-915Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Erlotinib: common questions

Is Erlotinib a prescription drug?
Yes. Erlotinib is a prescription (Rx) drug.
Who makes Erlotinib?
6 manufacturers list Erlotinib with the FDA, including Zydus Lifesciences Limited, Aurobindo Pharma Limited, Camber Pharmaceuticals, Inc.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/28/2024 · Label text is shown as published by the manufacturer. Not medical advice