FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
21695-641
11-digit product format
216950641
Labeler code
21695
Product ID
21695-641_ea6fac20-4c6b-42bb-8efd-c43458564fe7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
PASTE
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA040771
Marketing category
ANDA
Marketing start
2010-07-07
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
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
21695-641-052019-09-24C16284748780-1934fe258-4cef-48b1-e053-8cdaa90a720aTRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-641-05Triamcinolone Acetonide5 g in 1 TUBEPASTE51
21695-641-05Triamcinolone Acetonide1 in 1 CARTONPASTE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-641-05GM - Gram21695-641ffbfc506-0ab8-46c7-9339-f687ed69c22812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE PASTE [REBEL DISTRIBUTORS CORP]1
TRIAMCINOLONEACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE PASTE [REBEL DISTRIBUTORS CORP]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311TRIAMCINOLONE ACETONIDE PASTE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LTRIAMCINOLONE ACETONIDE PASTE [REBEL DISTRIBUTORS CORP]1
PECTIN, CITRUSINACTIVE INGREDIENT47EQO8LE7HTRIAMCINOLONE ACETONIDE PASTE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-641TRIAMCINOLONE ACETONIDE PASTE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20111118_ea6fac20-4c6b-42bb-8efd-c43458564fe7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-641-05216950641055 g in 1 TUBE5 gHistorical