FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
45802-065
11-digit product format
458020065
Labeler code
45802
Product ID
45802-065_afc14b16-9466-4a19-b454-c79d48d76fd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA086413
Marketing category
ANDA
Marketing start
2006-05-17
Substance
TRIAMCINOLONE ACETONIDE
Active strength
5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamcinolone Acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314, 1085644, 1085686

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-065-35Triamcinolone Acetonide1 in 1 CARTONCREAM119
45802-065-35Triamcinolone Acetonide15 g in 1 TUBECREAM1519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-065-35GM - Gram45802-065b8e0fe21-1e82-47a1-bb5c-ffa57687508312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7
WATERINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [PERRIGO NEW YORK INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-065TRIAMCINOLONE ACETONIDE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]19Current NDC, Legacy NDC, 2 package rows20250406_5d2fe6c2-3856-47f6-843f-077b2e1080a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085686triamcinolone acetonide 0.5 % Topical CreamPSN72038652-b15a-4a84-bccc-d50731ac5f03104
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD72038652-b15a-4a84-bccc-d50731ac5f03104
1085686triamcinolone acetonide 0.5 % Topical CreamSY72038652-b15a-4a84-bccc-d50731ac5f03104
1085686triamcinolone acetonide 0.5 % Topical CreamPSN0844a8f0-116d-40f6-8462-cccd6bcefc8a101
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD0844a8f0-116d-40f6-8462-cccd6bcefc8a101
1085686triamcinolone acetonide 0.5 % Topical CreamSY0844a8f0-116d-40f6-8462-cccd6bcefc8a101
1085644triamcinolone acetonide 0.025 % Topical CreamPSN5d2fe6c2-3856-47f6-843f-077b2e1080a019
1014314triamcinolone acetonide 0.1 % Topical CreamPSN5d2fe6c2-3856-47f6-843f-077b2e1080a019
1085686triamcinolone acetonide 0.5 % Topical CreamPSN5d2fe6c2-3856-47f6-843f-077b2e1080a019
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD5d2fe6c2-3856-47f6-843f-077b2e1080a019
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD5d2fe6c2-3856-47f6-843f-077b2e1080a019
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD5d2fe6c2-3856-47f6-843f-077b2e1080a019
1085644triamcinolone acetonide 0.025 % Topical CreamSY5d2fe6c2-3856-47f6-843f-077b2e1080a019
1014314triamcinolone acetonide 0.1 % Topical CreamSY5d2fe6c2-3856-47f6-843f-077b2e1080a019
1085686triamcinolone acetonide 0.5 % Topical CreamSY5d2fe6c2-3856-47f6-843f-077b2e1080a019
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY5d2fe6c2-3856-47f6-843f-077b2e1080a019
1085686triamcinolone acetonide 0.5 % Topical CreamPSN6a282425-8fdc-1fca-e053-2a91aa0a1c3a5
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD6a282425-8fdc-1fca-e053-2a91aa0a1c3a5
1085686triamcinolone acetonide 0.5 % Topical CreamSY6a282425-8fdc-1fca-e053-2a91aa0a1c3a5
1085644triamcinolone acetonide 0.025 % Topical CreamPSNd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1014314triamcinolone acetonide 0.1 % Topical CreamPSNd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1085686triamcinolone acetonide 0.5 % Topical CreamPSNd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1085644triamcinolone acetonide 0.025 % Topical CreamSYd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1014314triamcinolone acetonide 0.1 % Topical CreamSYd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1085686triamcinolone acetonide 0.5 % Topical CreamSYd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYd66d6c92-a3ab-40a9-9ae7-90d843ddaa364
1085686triamcinolone acetonide 0.5 % Topical CreamPSN1fbfadcb-35f2-0fc4-e063-6394a90af0d31
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD1fbfadcb-35f2-0fc4-e063-6394a90af0d31
1085686triamcinolone acetonide 0.5 % Topical CreamSY1fbfadcb-35f2-0fc4-e063-6394a90af0d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-065-35458020065351 TUBE in 1 CARTON (45802-065-35) / 15 g in 1 TUBE1 tube2006-05-170000-00-00NoNoCurrent