FDA.reportPublic FDA data

TRIAMCINOLONE ACETONIDE

Product NDC
67877-317
11-digit product format
678770317
Labeler code
67877
Product ID
67877-317_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
.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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
67877-317-152024-02-16C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-452024-02-16C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-802024-02-16C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-152024-01-30C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-452024-01-30C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-802024-01-30C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-152022-03-07C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-452022-03-07C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-802022-03-07C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-152022-01-28C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-452022-01-28C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d
67877-317-802022-01-28C16284748780-1d6a99b3a-01cf-a426-e053-dadaa90af4c2ccca8660-124e-4220-8d87-4b9aeecbda7d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-317-15TRIAMCINOLONE ACETONIDE15 g in 1 TUBECREAM1510
67877-317-45TRIAMCINOLONE ACETONIDE454 g in 1 TUBECREAM45410
67877-317-80TRIAMCINOLONE ACETONIDE80 g in 1 TUBECREAM8010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-317-15GM - Gram67877-3174d9299a0-b201-4d8e-ac9d-c810d26ce1ef12016-01-13
67877-317-45GM - Gram67877-3174c79f41a-bb8c-4687-80bb-3b1144f0794412016-01-13
67877-317-80GM - Gram67877-317cc8604bc-fe40-4685-9493-98f60429dd3512016-01-13

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-317TRIAMCINOLONE ACETONIDE CREAM [ASCEND LABORATORIES, LLC]10Current NDC, Legacy NDC, 3 package rows20240217_ccca8660-124e-4220-8d87-4b9aeecbda7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085644triamcinolone acetonide 0.025 % Topical CreamPSN3a85b137-7ef0-4b1d-8590-69c139355a13106
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD3a85b137-7ef0-4b1d-8590-69c139355a13106
1085644triamcinolone acetonide 0.025 % Topical CreamSY3a85b137-7ef0-4b1d-8590-69c139355a13106
1085644triamcinolone acetonide 0.025 % Topical CreamPSNb2ba93bc-3775-466b-8daf-4ffa3edc9c00104
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDb2ba93bc-3775-466b-8daf-4ffa3edc9c00104
1085644triamcinolone acetonide 0.025 % Topical CreamSYb2ba93bc-3775-466b-8daf-4ffa3edc9c00104
1085644triamcinolone acetonide 0.025 % Topical CreamPSN04ef72a9-6aa1-4d64-b598-f281215229a4100
1085644triamcinolone acetonide 0.025 % Topical CreamPSNb5297665-7979-4021-bfce-9119083a2a36100
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD04ef72a9-6aa1-4d64-b598-f281215229a4100
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDb5297665-7979-4021-bfce-9119083a2a36100
1085644triamcinolone acetonide 0.025 % Topical CreamSY04ef72a9-6aa1-4d64-b598-f281215229a4100
1085644triamcinolone acetonide 0.025 % Topical CreamSYb5297665-7979-4021-bfce-9119083a2a36100
1085644triamcinolone acetonide 0.025 % Topical CreamPSN96f18791-480d-49f2-aac6-387321ae552c42
1014314triamcinolone acetonide 0.1 % Topical CreamPSN96f18791-480d-49f2-aac6-387321ae552c42
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD96f18791-480d-49f2-aac6-387321ae552c42
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD96f18791-480d-49f2-aac6-387321ae552c42
1085644triamcinolone acetonide 0.025 % Topical CreamSY96f18791-480d-49f2-aac6-387321ae552c42
1014314triamcinolone acetonide 0.1 % Topical CreamSY96f18791-480d-49f2-aac6-387321ae552c42
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY96f18791-480d-49f2-aac6-387321ae552c42
1085644triamcinolone acetonide 0.025 % Topical CreamPSNccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 0.1 % Topical CreamPSNccca8660-124e-4220-8d87-4b9aeecbda7d10
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 CreamSCDccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCDccca8660-124e-4220-8d87-4b9aeecbda7d10
1085644triamcinolone acetonide 0.025 % Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 0.1 % Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1085686triamcinolone acetonide 0.5 % Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYccca8660-124e-4220-8d87-4b9aeecbda7d10
1085644triamcinolone acetonide 0.025 % Topical CreamPSNbd45c7d2-a1a3-e0f5-e053-2a95a90ae4b33
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDbd45c7d2-a1a3-e0f5-e053-2a95a90ae4b33
1085644triamcinolone acetonide 0.025 % Topical CreamSYbd45c7d2-a1a3-e0f5-e053-2a95a90ae4b33
1085644triamcinolone acetonide 0.025 % Topical CreamPSN557fa0fc-178f-4574-8a88-3c6d8e7cbc9b1
1085644triamcinolone acetonide 0.025 % Topical CreamPSNe4f5dcc2-b508-4b9a-b2ed-53c1ae80acbc1
1085644triamcinolone acetonide 0.025 % Topical CreamPSNd0428b54-c4f5-46f1-a65e-7e20c56dbe781
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDe4f5dcc2-b508-4b9a-b2ed-53c1ae80acbc1
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDd0428b54-c4f5-46f1-a65e-7e20c56dbe781
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD557fa0fc-178f-4574-8a88-3c6d8e7cbc9b1
1085644triamcinolone acetonide 0.025 % Topical CreamSYd0428b54-c4f5-46f1-a65e-7e20c56dbe781
1085644triamcinolone acetonide 0.025 % Topical CreamSY557fa0fc-178f-4574-8a88-3c6d8e7cbc9b1
1085644triamcinolone acetonide 0.025 % Topical CreamSYe4f5dcc2-b508-4b9a-b2ed-53c1ae80acbc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-317-156787703171515 g in 1 TUBE (67877-317-15) 15 g2012-04-010000-00-00NoNoCurrent
67877-317-4567877031745454 g in 1 TUBE (67877-317-45) 454 g2012-04-010000-00-00NoNoCurrent
67877-317-806787703178080 g in 1 TUBE (67877-317-80) 80 g2012-04-010000-00-00NoNoCurrent