MedPath

Sterile Talc

These highlights do not include all the information needed to use STERILE TALC POWDER safely and effectively. See full prescribing information for STERILE TALC POWDER. STERILE TALC POWDER (talc), for intrapleural use Initial U.S. Approval: 2003

Approved
Approval ID

72b10d15-8337-49ab-ad8d-0e990192598e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 5, 2014

Manufacturers
FDA

Bryan Corporation

DUNS: 147033401

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Talc

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code63256-200
Application NumberNDA021388
Product Classification
M
Marketing Category
C73594
G
Generic Name
Talc
Product Specifications
Route of AdministrationINTRAPLEURAL
Effective DateJune 5, 2014
FDA Product Classification

INGREDIENTS (1)

TalcActive
Quantity: 5 g in 100 mL
Code: 7SEV7J4R1U
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Sterile Talc - FDA Drug Approval Details