FDA.reportPublic FDA data

Triamcinolone acetonide

Product NDC
50436-0843
11-digit product format
504360843
Labeler code
50436
Product ID
50436-0843_a59b508d-509a-4da8-b53a-386199bf8c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA088042
Marketing category
ANDA
Marketing start
2012-04-01
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
50436-0843-12021-01-29C16284748780-1ba0f9c33-470a-a910-e053-dadaa90a0b8577c70769-8dad-4254-aac8-fb589804b004
50436-0843-22021-01-29C16284748780-1ba0f9c33-470a-a910-e053-dadaa90a0b8577c70769-8dad-4254-aac8-fb589804b004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0843-1Triamcinolone acetonide15 g in 1 TUBECREAM1510
50436-0843-2Triamcinolone acetonide80 g in 1 TUBECREAM8010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0843-1GM - Gram50436-08437a4516c2-5ae2-4115-862e-753ae56bcc5f12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
50436-0843TRIAMCINOLONE ACETONIDE CREAM TRIAMCINOLONE ACETONIDE CREAM [UNIT DOSE SERVICES]10Legacy NDC, 2 package rows20190926_77c70769-8dad-4254-aac8-fb589804b004.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN77c70769-8dad-4254-aac8-fb589804b00410
1085686triamcinolone acetonide 0.5 % Topical CreamPSN77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD77c70769-8dad-4254-aac8-fb589804b00410
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 0.1 % Topical CreamSY77c70769-8dad-4254-aac8-fb589804b00410
1085686triamcinolone acetonide 0.5 % Topical CreamSY77c70769-8dad-4254-aac8-fb589804b00410
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY77c70769-8dad-4254-aac8-fb589804b00410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-0843-15043608430115 g in 1 TUBE15 gHistorical
50436-0843-25043608430280 g in 1 TUBE80 gHistorical