Quick answers
- What is Erlotinib used for?
- The FDA-approved label (Erlotinib, Camber Pharmaceuticals, Inc., June 26, 2024) says: “Erlotinib tablets are a kinase inhibitor indicated for: • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Erlotinib have a boxed warning?
- No. None of the 11 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Erlotinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Erlotinib been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Erlotinib?
- 9 companies list prescription products of Erlotinib in the FDA NDC Directory, including Armas Pharmaceuticals Inc., Aurobindo Pharma Limited and Teva Pharmaceuticals USA, Inc..
What Erlotinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Erlotinib tablets are a kinase inhibitor indicated for: • The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy …
— FDA label: Erlotinib, Camber Pharmaceuticals, Inc., effective June 26, 2024. Read the full label on DailyMed →
The FDA has 11 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 27 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Armas Pharmaceuticals Inc.3 products
- Aurobindo Pharma Limited3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Alembic Pharmaceuticals Limited3 products
- Camber Pharmaceuticals, Inc.3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Zydus Lifesciences Limited3 products
- Novadoz Pharmaceuticals LLC3 products
- Alembic Pharmaceuticals Inc.3 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (7)
- ANDA091059Teva Pharms USA Inc · August 28, 2015
- ANDA211960Adaptis · November 5, 2019
- ANDA213065Zydus Pharms · April 16, 2020
- ANDA214366Msn · May 10, 2021
- ANDA214719Alembic · July 8, 2021
- ANDA216342Eugia Pharma · June 22, 2022
- ANDA209267Hetero Labs Ltd V · May 24, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 603203, 603206, 603208 |
|---|---|
| SPL set ID of the quoted label | a3b2d622-b4d5-4819-862b-f8fd3adcec6f |
| FDA labels (SPL) | 11 |
| FDA applications | 7 ANDA |
| Active ingredients (FDA) | ERLOTINIB |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Erlotinib, Camber Pharmaceuticals, Inc., effective June 26, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →