FDA.reportPublic FDA data

triamcinolone acetonide

Product NDC
21695-504
11-digit product format
216950504
Labeler code
21695
Product ID
21695-504_3f33ae63-5653-4a75-9f74-19d40ae20209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rebel Distributors Corp
Application
ANDA085691
Marketing category
ANDA
Marketing start
2009-10-07
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
21695-504-152019-09-24C16284748780-1934fe258-48cf-48b1-e053-8cdaa90a720aTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%
21695-504-802019-09-24C16284748780-1934fe258-48cf-48b1-e053-8cdaa90a720aTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-504-15triamcinolone acetonide15 g in 1 TUBEOINTMENT151
21695-504-80triamcinolone acetonide80 g in 1 TUBEOINTMENT801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-504-15GM - Gram21695-5048fc39912-c661-4696-8e5d-a8d5e3076f9512012-07-24
21695-504-80GM - Gram21695-504876df46a-2fc9-40a5-ac2c-d63f0a39221d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1
TriamcinoloneACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-504TRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101210_3f33ae63-5653-4a75-9f74-19d40ae20209.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085633triamcinolone acetonide 0.025 % Topical OintmentPSN3f33ae63-5653-4a75-9f74-19d40ae202091
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN3f33ae63-5653-4a75-9f74-19d40ae202091
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCD3f33ae63-5653-4a75-9f74-19d40ae202091
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD3f33ae63-5653-4a75-9f74-19d40ae202091
1085633triamcinolone acetonide 0.025 % Topical OintmentSY3f33ae63-5653-4a75-9f74-19d40ae202091
1085636triamcinolone acetonide 0.1 % Topical OintmentSY3f33ae63-5653-4a75-9f74-19d40ae202091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
21695-504-152169505041515 g in 1 TUBE15 gHistorical
21695-504-802169505048080 g in 1 TUBE80 gHistorical