FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
68071-4945
11-digit product format
680714945
Labeler code
68071
Product ID
68071-4945_1b2e2e40-6134-401a-e063-6294a90a8c8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209535
Marketing category
ANDA
Marketing start
2018-05-19
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triamcinolone Acetonide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314

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
68071-4945-52024-06-18C16284748780-1ba0f9c33-1305-a910-e053-dadaa90a0b85Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% Rx only
68071-4945-52021-01-29C16284748780-1ba0f9c33-1305-a910-e053-dadaa90a0b85Triamcinolone Acetonide Cream USP, 0.025%, 0.1%, 0.5% Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4945-5Triamcinolone Acetonide15 g in 1 BOXCREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4945TRIAMCINOLONE ACETONIDE CREAM [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 1 package rows20240619_8c4026de-9e91-c95d-e053-2a95a90a6903.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN8c4026de-9e91-c95d-e053-2a95a90a69032
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD8c4026de-9e91-c95d-e053-2a95a90a69032
1014314triamcinolone acetonide 0.1 % Topical CreamSY8c4026de-9e91-c95d-e053-2a95a90a69032
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY8c4026de-9e91-c95d-e053-2a95a90a69032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-4945-56807149450515 g in 1 BOX (68071-4945-5) 15 g2019-06-26NoNoHistorical