FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
45802-063
11-digit product format
458020063
Labeler code
45802
Product ID
45802-063_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
2006-10-09
Substance
TRIAMCINOLONE ACETONIDE
Active strength
.25 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 ACETONIDE.25 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
45802-063-05Triamcinolone Acetonide454 g in 1 JARCREAM45419
45802-063-35Triamcinolone Acetonide15 g in 1 TUBECREAM1519
45802-063-35Triamcinolone Acetonide1 in 1 CARTONCREAM119
45802-063-36Triamcinolone Acetonide80 g in 1 TUBECREAM8019
45802-063-36Triamcinolone Acetonide1 in 1 CARTONCREAM119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-063-05GM - Gram45802-0639b3734f3-7996-4807-b4be-4480d66de05812012-07-24
45802-063-35GM - Gram45802-063df14049a-ba5f-44cd-b7dd-3e9a3bbe257512012-07-24
45802-063-36GM - Gram45802-063395d4527-b575-4ae5-94b0-6494b18f8e6e12012-07-24

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
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
TRIAMCINOLONEACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-063TRIAMCINOLONE ACETONIDE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]19Current NDC, Legacy NDC, 5 package rows20250406_5d2fe6c2-3856-47f6-843f-077b2e1080a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
1085644triamcinolone acetonide 0.025 % Topical CreamPSN78e3efd6-a815-460d-92ae-46d7776990cd5
1014314triamcinolone acetonide 0.1 % Topical CreamPSN78e3efd6-a815-460d-92ae-46d7776990cd5
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD78e3efd6-a815-460d-92ae-46d7776990cd5
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD78e3efd6-a815-460d-92ae-46d7776990cd5
1085644triamcinolone acetonide 0.025 % Topical CreamSY78e3efd6-a815-460d-92ae-46d7776990cd5
1014314triamcinolone acetonide 0.1 % Topical CreamSY78e3efd6-a815-460d-92ae-46d7776990cd5
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY78e3efd6-a815-460d-92ae-46d7776990cd5
1085644triamcinolone acetonide 0.025 % Topical CreamPSNda474ee7-ac67-4e62-991d-ca979f13dea24
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 CreamSCDda474ee7-ac67-4e62-991d-ca979f13dea24
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 CreamSYda474ee7-ac67-4e62-991d-ca979f13dea24
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
1085644triamcinolone acetonide 0.025 % Topical CreamPSN69786597-99f9-4bdc-91bc-c50e5fd682c82
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD69786597-99f9-4bdc-91bc-c50e5fd682c82
1085644triamcinolone acetonide 0.025 % Topical CreamSY69786597-99f9-4bdc-91bc-c50e5fd682c82
1085644triamcinolone acetonide 0.025 % Topical CreamPSN96549128-b031-4abd-a410-c7b1a877ce651
1014314triamcinolone acetonide 0.1 % Topical CreamPSN96549128-b031-4abd-a410-c7b1a877ce651
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD96549128-b031-4abd-a410-c7b1a877ce651
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD96549128-b031-4abd-a410-c7b1a877ce651
1085644triamcinolone acetonide 0.025 % Topical CreamSY96549128-b031-4abd-a410-c7b1a877ce651
1014314triamcinolone acetonide 0.1 % Topical CreamSY96549128-b031-4abd-a410-c7b1a877ce651
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY96549128-b031-4abd-a410-c7b1a877ce651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-063-0545802006305454 g in 1 JAR (45802-063-05) 454 g2006-12-210000-00-00NoNoCurrent
45802-063-35458020063351 TUBE in 1 CARTON (45802-063-35) / 15 g in 1 TUBE1 tube2007-07-110000-00-00NoNoCurrent
45802-063-36458020063361 TUBE in 1 CARTON (45802-063-36) / 80 g in 1 TUBE1 tube2006-10-090000-00-00NoNoCurrent