TUBERSOL
Tuberculin Purified Protein Derivative(Mantoux)TUBERSOL
Approved
Approval ID
261efc52-a105-4c2c-a8ce-9eee20b62efc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tuberculin Purified Protein Derivative
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-0261
Application NumberBLA103941
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tuberculin Purified Protein Derivative
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateNovember 9, 2021
FDA Product Classification
INGREDIENTS (3)
TUBERCULIN PURIFIED PROTEIN DERIVATIVEActive
Quantity: 5 [iU] in 0.1 mL
Code: I7L8FKN87J
Classification: ACTIB
Polysorbate 80Inactive
Quantity: 0.0125 uL in 0.1 mL
Code: 6OZP39ZG8H
Classification: IACT
PhenolInactive
Quantity: 0.35 mg in 0.1 mL
Code: 339NCG44TV
Classification: IACT