FDA.reportPublic FDA data

triamcinolone acetonide

Product NDC
52565-056
11-digit product format
525650056
Labeler code
52565
Product ID
52565-056_68429a04-764e-44ec-8359-0050d9dd5544
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208848
Marketing category
ANDA
Marketing start
2017-04-17
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
2022-12-31
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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
1629e00f-54fb-4a43-8306-b58442b23902Product name920200430
5331c9c8-f64b-11e6-ccf1-071c477fcb0bProduct name720190612
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-056-152023-01-30C16284748780-1f386c649-ef41-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE CREAM USP, 0.1%
52565-056-262023-01-30C16284748780-1f386c649-ef41-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE CREAM USP, 0.1%
52565-056-302023-01-30C16284748780-1f386c649-ef41-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE CREAM USP, 0.1%
52565-056-802023-01-30C16284748780-1f386c649-ef41-0266-e053-dadaa90a7c1aTRIAMCINOLONE ACETONIDE CREAM USP, 0.1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-056-15triamcinolone acetonide15 g in 1 TUBECREAM155
52565-056-15triamcinolone acetonide1 in 1 CARTONCREAM15
52565-056-26triamcinolone acetonide454 g in 1 JARCREAM4545
52565-056-26triamcinolone acetonide1 in 1 CARTONCREAM15
52565-056-30triamcinolone acetonide1 in 1 CARTONCREAM15
52565-056-30triamcinolone acetonide30 g in 1 TUBECREAM305
52565-056-80triamcinolone acetonide1 in 1 CARTONCREAM15
52565-056-80triamcinolone acetonide80 g in 1 TUBECREAM805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-056-15GM - Gram52565-0562ed31ba8-9676-42f4-982b-533f2b92eff212017-11-06
52565-056-26GM - Gram52565-0569a8f4540-e182-456b-9702-dbb40472dd7412018-04-19
52565-056-30GM - Gram52565-05646eeaad7-eb03-442b-856c-52c73552099712017-11-06
52565-056-80GM - Gram52565-05656f5bac5-a805-4763-9adb-e8b360f3b40f12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-056TRIAMCINOLONE ACETONIDE CREAM [TELIGENT PHARMA, INC.]5Legacy NDC, 8 package rows20210916_f660c29d-1a39-32e8-567e-ed6dd96fde8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSNf660c29d-1a39-32e8-567e-ed6dd96fde8d5
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDf660c29d-1a39-32e8-567e-ed6dd96fde8d5
1014314triamcinolone acetonide 0.1 % Topical CreamSYf660c29d-1a39-32e8-567e-ed6dd96fde8d5
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYf660c29d-1a39-32e8-567e-ed6dd96fde8d5
1014314triamcinolone acetonide 0.1 % Topical CreamPSN69aec845-3d4a-d226-e053-2991aa0afd124
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD69aec845-3d4a-d226-e053-2991aa0afd124
1014314triamcinolone acetonide 0.1 % Topical CreamSY69aec845-3d4a-d226-e053-2991aa0afd124
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY69aec845-3d4a-d226-e053-2991aa0afd124
1014314triamcinolone acetonide 0.1 % Topical CreamPSNd12192f0-5320-4fe0-a5ca-526ee7e9dbcd3
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDd12192f0-5320-4fe0-a5ca-526ee7e9dbcd3
1014314triamcinolone acetonide 0.1 % Topical CreamSYd12192f0-5320-4fe0-a5ca-526ee7e9dbcd3
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYd12192f0-5320-4fe0-a5ca-526ee7e9dbcd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-056-15525650056151 TUBE in 1 CARTON (52565-056-15) > 15 g in 1 TUBE1 tube2017-04-170000-00-00NoNoCurrent
52565-056-26525650056261 JAR in 1 CARTON (52565-056-26) > 454 g in 1 JAR1 jar2018-01-290000-00-00NoNoCurrent
52565-056-30525650056301 TUBE in 1 CARTON (52565-056-30) > 30 g in 1 TUBE1 tube2017-04-170000-00-00NoNoCurrent
52565-056-80525650056801 TUBE in 1 CARTON (52565-056-80) > 80 g in 1 TUBE1 tube2017-04-170000-00-00NoNoCurrent