TUBERSOL
Tuberculin Purified Protein Derivative(Mantoux)TUBERSOL
Approved
Approval ID
96d91ba3-9dfe-4420-a835-57647ea30b40
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2972
Application NumberBLA103941
Product Classification
M
Marketing Category
C73585
G
Generic Name
Tuberculin Purified Protein Derivative
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateMay 22, 2013
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