FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
68258-3978
11-digit product format
682583978
Labeler code
68258
Product ID
68258-3978_52eeaf00-babe-4eab-916f-47834846eec4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA087385
Marketing category
ANDA
Marketing start
2006-11-10
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
5 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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
68258-3978-12019-11-27C16284748780-19855d018-ed77-cd31-e053-dbdaa90ab51aTRIAMCINOLONE ACETONIDE OINTMENT USP 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68258-3978-1Triamcinolone Acetonide15 g in 1 TUBEOINTMENT151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68258-3978-1GM - Gram68258-39786fedb384-3aec-44b1-b559-488624e47fe512013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [DISPENSING SOLUTIONS, INC.]1
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [DISPENSING SOLUTIONS, INC.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE OINTMENT [DISPENSING SOLUTIONS, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68258-3978TRIAMCINOLONE ACETONIDE OINTMENT [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130724_f899d94c-a661-424d-a3f7-1c41286b6e1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085640triamcinolone acetonide 0.5 % Topical OintmentPSNf899d94c-a661-424d-a3f7-1c41286b6e1c1
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCDf899d94c-a661-424d-a3f7-1c41286b6e1c1
1085640triamcinolone acetonide 0.5 % Topical OintmentSYf899d94c-a661-424d-a3f7-1c41286b6e1c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68258-3978-16825839780115 g in 1 TUBE15 gHistorical