Prescription medicine
Tuberculin purified protein derivative Brand names: Tubersol, Aplisol
Tuberculin purified protein derivative (Aplisol) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tuberculin purified protein derivative FDA label on DailyMed (effective May 1, 2026); every tuberculin purified protein derivative label on DailyMed.
Highlights of the record
FDA label of May 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease.
Forms and strengths
- 0.1ml
Injection (solution); injection.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 1,852 through July 30, 2026
What is tuberculin purified protein derivative used for?
From the label: indications and usageTUBERSOL Tuberculin Purified Protein Derivative (Mantoux), is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk of developing active disease. The Centers for Disease Control and Prevention (CDC) have published guidelines regarding populations that would benefit from tuberculin skin testing (TST). Current recommendations can be accessed at: http://www.cdc.gov/tb/publications/factsheets/testing.htm. Previous BCG vaccination is not a contraindication to tuberculin testing. The skin-test results of BCG vaccinated persons can be used to support or exclude the diagnosis of TB infection. […]
FDA pharmacologic class: Skin Test Antigen and Tuberculosis Skin Test.
Source: FDA drug label (TUBERSOL), Sanofi Vaccines US Inc., effective May 1, 2026 (SPL set a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd), via openFDA; the full label on DailyMed
Is there a generic for tuberculin purified protein derivative (Aplisol)?
No generic tuberculin purified protein derivative is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has tuberculin purified protein derivative been recalled?
The FDA's Enforcement Report lists 1 recall naming tuberculin purified protein derivative since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tuberculin purified protein derivative label say about other medicines?
The tuberculin purified protein derivative label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Epinephrine | warnings | WARNINGS Hypersensitivity Allergic reactions may occur following the use of TUBERSOL even in persons with no prior history of hypersensitivity to the product components. (10) Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available. |
Check tuberculin purified protein derivative against other medicines
Source: FDA drug label (TUBERSOL), Sanofi Vaccines US Inc., effective May 1, 2026 (SPL set a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd), via openFDA; the full label on DailyMed
What do FAERS reports show for tuberculin purified protein derivative?
The FDA Adverse Event Reporting System holds 1,852 reports that list tuberculin purified protein derivative among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 143 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other skin test antigens
- the pharmacologic class, with prices and generics
- Tuberculin purified protein derivative side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other