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Triamcinolone Acetonide

Triamcinolone Acetonide Ointment USP, 0.025%, 0.1%, 0.5%

Approved
Approval ID

93041e9c-3320-4617-b1c1-68c95bf6b770

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 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.

Triamcinolone Acetonide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-0362
Application NumberANDA087385
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triamcinolone Acetonide
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 28, 2021
FDA Product Classification

INGREDIENTS (3)

TRIAMCINOLONE ACETONIDEActive
Quantity: 0.25 mg in 1 g
Code: F446C597KA
Classification: ACTIB
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 11/22/2016

DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5.

Triamcinolone Acetonide Chemical Structure

Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.

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Triamcinolone Acetonide - FDA Drug Approval Details