FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
61919-234
11-digit product format
619190234
Labeler code
61919
Product ID
61919-234_4ef62c9f-cf62-6ad7-e063-6394a90a2774
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Direct_Rx
Application
ANDA088042
Marketing category
ANDA
Marketing start
2026-03-16
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamcinolone Acetonide
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-234-152020-01-31C16284748780-19d75b9d0-7a89-f424-e053-dadaa90a57ceTRIAMCINOLONE ACETONIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-234-15TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM152
61919-234-30Triamcinolone Acetonide30 g in 1 TUBECREAM302
61919-234-80Triamcinolone Acetonide80 g in 1 TUBECREAM802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-234-15GM - Gram61919-23412630457-670c-4ff3-949c-2c00e9b324ab12015-03-03
61919-234-30GM - Gram61919-23472a7770a-ff00-4e5e-b823-db142e558a9112026-04-20
61919-234-80GM - Gram61919-2341876d610-b523-441e-9262-1c0b46ca03b612026-04-20

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-234TRIAMCINOLONE ACETONIDE CREAM [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20151106_f8bef2de-8fc1-4fe3-91cc-f88c87868bec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 0.1 % Topical CreamPSNf8bef2de-8fc1-4fe3-91cc-f88c87868bec2
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDf8bef2de-8fc1-4fe3-91cc-f88c87868bec2
1014314triamcinolone acetonide 0.1 % Topical CreamSY4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 0.1 % Topical CreamSYf8bef2de-8fc1-4fe3-91cc-f88c87868bec2
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYf8bef2de-8fc1-4fe3-91cc-f88c87868bec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61919-234-156191902341515 g in 1 TUBE15 gHistorical
61919-234-306191902343030 g in 1 TUBE (61919-234-30) 30 g2026-03-16NoNoCurrent
61919-234-806191902348080 g in 1 TUBE (61919-234-80) 80 g2026-03-16NoNoCurrent