TUBERSOL
Tuberculin Purified Protein Derivative(Mantoux)TUBERSOL
Approved
Approval ID
a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Sanofi Pasteur Inc.
DUNS: 086723285
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 Code49281-752
Application NumberBLA103941
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tuberculin Purified Protein Derivative
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateJanuary 25, 2024
FDA Product Classification
INGREDIENTS (3)
Tuberculin Purified Protein DerivativeActive
Quantity: 5 [iU] in 0.1 mL
Code: I7L8FKN87J
Classification: ACTIB
PhenolInactive
Quantity: 0.35 mg in 0.1 mL
Code: 339NCG44TV
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.0125 uL in 0.1 mL
Code: 6OZP39ZG8H
Classification: IACT