FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
52959-096
11-digit product format
529590096
Labeler code
52959
Product ID
52959-096_0899cb6a-c841-479f-aabb-28560c1fda74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA086414
Marketing category
ANDA
Marketing start
2006-09-28
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d4d7da1a-7fd4-628e-cdae-89e749b1c534Product name720260127
75f7e47b-8736-a182-fc44-22aca8d79689Product name220251211
62986c8d-91f1-b1ba-b5a3-8b54b75bb8c2Product name620250516
e42f429b-c4e5-0402-e1c5-730154df4060Product name420240205
38d4de13-64b3-4057-b91c-4b5126962341Product name120220516
089e0644-1ea8-8654-4113-39f960dd57d5Product name320210115
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
9f64e0dc-109c-9660-8e0e-91ec987b3817Product name620171204
dfa879a3-32de-49f0-a7ba-9b9c3e13002fProduct name120171204
8de20f81-8411-4cf1-a8b2-03404ee56d01Product name320171109
a5f1a68c-0352-4f34-46a3-9b4eed239ed8Product name220160819
355b2224-0895-7135-83f5-d099a6a82a0aProduct name120140508
55be6b50-8cc0-f0f1-74a1-3416a91193aaProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-096-152020-01-31C16284748780-19d75b9d0-2bb7-f424-e053-dadaa90a57ceTRIAMCINOLONE ACETONIDE, USP CREAM
52959-096-302020-01-31C16284748780-19d75b9d0-2bb7-f424-e053-dadaa90a57ceTRIAMCINOLONE ACETONIDE, USP CREAM
52959-096-452020-01-31C16284748780-19d75b9d0-2bb7-f424-e053-dadaa90a57ceTRIAMCINOLONE ACETONIDE, USP CREAM
52959-096-802020-01-31C16284748780-19d75b9d0-2bb7-f424-e053-dadaa90a57ceTRIAMCINOLONE ACETONIDE, USP CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-096-15Triamcinolone Acetonide1 in 1 CARTONCREAM11
52959-096-15Triamcinolone Acetonide15 g in 1 TUBECREAM151
52959-096-30Triamcinolone Acetonide30 g in 1 TUBECREAM301
52959-096-30Triamcinolone Acetonide1 in 1 CARTONCREAM11
52959-096-45Triamcinolone Acetonide1 in 1 CARTONCREAM11
52959-096-45Triamcinolone Acetonide45 g in 1 TUBECREAM451
52959-096-80Triamcinolone Acetonide1 in 1 CARTONCREAM11
52959-096-80Triamcinolone Acetonide80 g in 1 TUBECREAM801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-096-30GM - Gram52959-0962327c531-50a9-4ae0-9a64-0e503ba7c0b412015-10-02
52959-096-45GM - Gram52959-0963de7a48f-be79-4db4-befe-bf7e2b4ddc9712012-07-24
52959-096-80GM - Gram52959-0969873a24b-fdf3-4473-8770-94665f823bf012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
TRIAMCINOLONEACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-096TRIAMCINOLONE ACETONIDE CREAM [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 8 package rows20111209_b6e1d86b-fc9a-486d-a6e5-7e82ac1b09ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSNb6e1d86b-fc9a-486d-a6e5-7e82ac1b09ba1
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDb6e1d86b-fc9a-486d-a6e5-7e82ac1b09ba1
1014314triamcinolone acetonide 0.1 % Topical CreamSYb6e1d86b-fc9a-486d-a6e5-7e82ac1b09ba1
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYb6e1d86b-fc9a-486d-a6e5-7e82ac1b09ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-096-15529590096151 in 1 CARTONHistorical
52959-096-305295900963030 g in 1 TUBE30 gHistorical
52959-096-45529590096451 in 1 CARTONHistorical
52959-096-80529590096801 in 1 CARTONHistorical