FDA.reportPublic FDA data

TRIAMCINOLONE ACETONIDE

Product NDC
67877-318
11-digit product format
678770318
Labeler code
67877
Product ID
67877-318_80a645ba-22f3-4af5-abc9-daab0a20acf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Ascend Laboratories, LLC
Application
ANDA088042
Marketing category
ANDA
Marketing start
2012-04-01
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67877-318-152024-02-16C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-318-152024-01-30C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-318-152022-03-07C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-318-152022-01-28C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-318-15TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM1510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-318-15GM - Gram67877-318c0a187c3-3276-40aa-ab86-511adc28bc0b12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XTRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
SORBITOLINACTIVE INGREDIENT506T60A25RTRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]5
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [UNIT DOSE SERVICES]3
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-318TRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]10Current NDC, Legacy NDC, 1 package rows20240217_ccca8660-124e-4220-8d87-4b9aeecbda7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085686triamcinolone acetonide 0.5 % Topical CreamPSNf152b99c-5363-40f9-9fad-c3e36b7c3df1107
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDf152b99c-5363-40f9-9fad-c3e36b7c3df1107
1085686triamcinolone acetonide 0.5 % Topical CreamSYf152b99c-5363-40f9-9fad-c3e36b7c3df1107
1085686triamcinolone acetonide 0.5 % Topical CreamPSNf549f9ea-abc0-4fc2-b6ec-c21182eb26e6101
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDf549f9ea-abc0-4fc2-b6ec-c21182eb26e6101
1085686triamcinolone acetonide 0.5 % Topical CreamSYf549f9ea-abc0-4fc2-b6ec-c21182eb26e6101
1085686triamcinolone acetonide 0.5 % Topical CreamPSN20fa27ca-807a-4513-8af5-a835541d60d5100
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD20fa27ca-807a-4513-8af5-a835541d60d5100
1085686triamcinolone acetonide 0.5 % Topical CreamSY20fa27ca-807a-4513-8af5-a835541d60d5100
1085686triamcinolone acetonide 0.5 % Topical CreamPSN7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d19
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d19
1085686triamcinolone acetonide 0.5 % Topical CreamSY7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d19
1085686triamcinolone acetonide 0.5 % Topical CreamPSN87045b25-4d54-44fa-baed-1aefdad9857411
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD87045b25-4d54-44fa-baed-1aefdad9857411
1085686triamcinolone acetonide 0.5 % Topical CreamSY87045b25-4d54-44fa-baed-1aefdad9857411
1085644triamcinolone acetonide 0.025 % Topical CreamPSNccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 0.1 % Topical CreamPSN77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 0.1 % Topical CreamPSNccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 0.5 % Topical CreamPSN77c70769-8dad-4254-aac8-fb589804b00410
1085686triamcinolone acetonide 0.5 % Topical CreamPSNccca8660-124e-4220-8d87-4b9aeecbda7d10
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD77c70769-8dad-4254-aac8-fb589804b00410
1085644triamcinolone acetonide 0.025 % Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 0.1 % Topical CreamSY77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 0.1 % Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 0.5 % Topical CreamSY77c70769-8dad-4254-aac8-fb589804b00410
1085686triamcinolone acetonide 0.5 % Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 0.5 % Topical CreamPSN4ebb08c5-d822-46a0-8912-da6e79fc4a0a5
1085686triamcinolone acetonide 0.5 % Topical CreamPSN7a2392c6-d26f-4def-8c7d-8b79e384c5225
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD7a2392c6-d26f-4def-8c7d-8b79e384c5225
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD4ebb08c5-d822-46a0-8912-da6e79fc4a0a5
1085686triamcinolone acetonide 0.5 % Topical CreamSY7a2392c6-d26f-4def-8c7d-8b79e384c5225
1085686triamcinolone acetonide 0.5 % Topical CreamSY4ebb08c5-d822-46a0-8912-da6e79fc4a0a5
1085686triamcinolone acetonide 0.5 % Topical CreamPSNb43d4e4a-6206-4449-e053-2a95a90a721a3
1085686triamcinolone acetonide 0.5 % Topical CreamPSN777c3cb9-da2b-431c-934f-f3c70f93d6cb3
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDb43d4e4a-6206-4449-e053-2a95a90a721a3
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD777c3cb9-da2b-431c-934f-f3c70f93d6cb3
1085686triamcinolone acetonide 0.5 % Topical CreamSYb43d4e4a-6206-4449-e053-2a95a90a721a3
1085686triamcinolone acetonide 0.5 % Topical CreamSY777c3cb9-da2b-431c-934f-f3c70f93d6cb3
1085686triamcinolone acetonide 0.5 % Topical CreamPSN7d645a6a-17bd-3043-e053-2a91aa0a195d1
1085686triamcinolone acetonide 0.5 % Topical CreamPSN1d8b09b2-ba86-ef6e-e063-6294a90a05eb1
1085686triamcinolone acetonide 0.5 % Topical CreamPSN50a2d9c7-28c7-4f8d-b0cf-d017da0f0cd91
1085686triamcinolone acetonide 0.5 % Topical CreamPSN1e1b7f92-31bf-9c6b-e063-6394a90accc01
1085686triamcinolone acetonide 0.5 % Topical CreamPSNdca8a049-307d-45e4-bcf8-988ca7a3c9421
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD7d645a6a-17bd-3043-e053-2a91aa0a195d1
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD1e1b7f92-31bf-9c6b-e063-6394a90accc01
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDdca8a049-307d-45e4-bcf8-988ca7a3c9421
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD50a2d9c7-28c7-4f8d-b0cf-d017da0f0cd91
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD1d8b09b2-ba86-ef6e-e063-6294a90a05eb1
1085686triamcinolone acetonide 0.5 % Topical CreamSYdca8a049-307d-45e4-bcf8-988ca7a3c9421
1085686triamcinolone acetonide 0.5 % Topical CreamSY50a2d9c7-28c7-4f8d-b0cf-d017da0f0cd91
1085686triamcinolone acetonide 0.5 % Topical CreamSY1e1b7f92-31bf-9c6b-e063-6394a90accc01
1085686triamcinolone acetonide 0.5 % Topical CreamSY7d645a6a-17bd-3043-e053-2a91aa0a195d1
1085686triamcinolone acetonide 0.5 % Topical CreamSY1d8b09b2-ba86-ef6e-e063-6294a90a05eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-318-156787703181515 g in 1 TUBE (67877-318-15) 15 g2012-04-010000-00-00NoNoCurrent