FDA.reportPublic FDA data

Triamcinolone acetonide

Product NDC
63187-025
11-digit product format
631870025
Labeler code
63187
Product ID
63187-025_acfb28ae-e638-40bf-83d1-67605ff00078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA088042
Marketing category
ANDA
Marketing start
2012-04-01
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 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 ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314

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
63187-025-15Triamcinolone acetonide15 g in 1 TUBECREAM156
63187-025-30Triamcinolone acetonide30 g in 1 TUBECREAM306
63187-025-80Triamcinolone acetonide80 g in 1 TUBECREAM806

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-025-15GM - Gram63187-0250570cb91-a0b6-41a1-9eca-b1404c7b4cb612015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]2
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-025TRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20240129_7dc12943-7702-4c84-b507-2ea207d02460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN7dc12943-7702-4c84-b507-2ea207d024606
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD7dc12943-7702-4c84-b507-2ea207d024606
1014314triamcinolone acetonide 0.1 % Topical CreamSY7dc12943-7702-4c84-b507-2ea207d024606
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY7dc12943-7702-4c84-b507-2ea207d024606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-025-156318700251515 g in 1 TUBE (63187-025-15) 15 g2018-11-010000-00-00NoNoCurrent
63187-025-306318700253030 g in 1 TUBE (63187-025-30) 30 g2018-11-010000-00-00NoNoCurrent
63187-025-806318700258080 g in 1 TUBE (63187-025-80) 80 g2018-11-010000-00-00NoNoCurrent