FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
52817-811
11-digit product format
528170811
Labeler code
52817
Product ID
52817-811_29f726e6-3d7e-2c5e-e063-6294a90a90c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
TruPharma, LLC
Application
ANDA040671
Marketing category
ANDA
Marketing start
2022-02-10
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
52817-811-54Triamcinolone Acetonide454 g in 1 JARCREAM4542

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-811-54GM - Gram52817-8112b07c473-18d0-4869-b1a4-c5fc720d4c5612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-811TRIAMCINOLONE ACETONIDE CREAM [TRUPHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20241225_888f2b6f-1d11-4774-9eab-714af40edb7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN888f2b6f-1d11-4774-9eab-714af40edb7d2
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD888f2b6f-1d11-4774-9eab-714af40edb7d2
1014314triamcinolone acetonide 0.1 % Topical CreamSY888f2b6f-1d11-4774-9eab-714af40edb7d2
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY888f2b6f-1d11-4774-9eab-714af40edb7d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-811-15528170811151 TUBE in 1 CARTON (52817-811-15) > 15 g in 1 TUBE1 tube2022-02-100000-00-00NoNoCurrent
52817-811-30528170811301 TUBE in 1 CARTON (52817-811-30) > 30 g in 1 TUBE1 tube2022-02-100000-00-00NoNoCurrent
52817-811-5452817081154454 g in 1 JAR (52817-811-54) 454 g2022-02-100000-00-00NoNoCurrent
52817-811-80528170811801 TUBE in 1 CARTON (52817-811-80) > 80 g in 1 TUBE1 tube2022-02-100000-00-00NoNoCurrent