MedPath

Kenalog-40

KENALOG-40 INJECTION triamcinolone acetonide injectable suspension, USP

Approved
Approval ID

d53c1531-3864-4d07-8af2-31f7b5529d5c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2010

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.

triamcinolone acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-0235
Application NumberNDA014901
Product Classification
M
Marketing Category
C73594
G
Generic Name
triamcinolone acetonide
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRA-ARTICULAR
Effective DateMarch 17, 2011
FDA Product Classification

INGREDIENTS (8)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
TRIAMCINOLONE ACETONIDEActive
Quantity: 40 mg in 1 mL
Code: F446C597KA
Classification: ACTIB
NITROGENInactive
Code: N762921K75
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT

MedPath

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

© 2025 MedPath, Inc. All rights reserved.

Kenalog-40 - FDA Drug Approval Details