FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
0713-0655
11-digit product format
007130655
Labeler code
0713
Product ID
0713-0655_ee9c5cfd-2bcc-eee9-e053-2a95a90aeef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
PASTE
Route
DENTAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA205592
Marketing category
ANDA
Marketing start
2017-01-13
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
Rxcui1085728

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0655-40Triamcinolone Acetonide1 in 1 CARTONPASTE14
0713-0655-40Triamcinolone Acetonide5 g in 1 TUBEPASTE54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0655-40GM - Gram0713-0655b64369f2-5efb-4e10-bced-d5f1bb93698a12017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0655TRIAMCINOLONE ACETONIDE PASTE [COSETTE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20221130_d2095a36-3fcf-7c20-95e5-e046b014565f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085728triamcinolone acetonide 0.1 % Oral PastePSNd2095a36-3fcf-7c20-95e5-e046b014565f4
1085728triamcinolone acetonide 0.001 MG/MG Oral PasteSCDd2095a36-3fcf-7c20-95e5-e046b014565f4
1085728triamcinolone acetonide 0.1 % Dental PasteSYd2095a36-3fcf-7c20-95e5-e046b014565f4
1085728triamcinolone acetonide 1 MG per GM Oral PasteSYd2095a36-3fcf-7c20-95e5-e046b014565f4
1085728triamcinolone acetonide 0.1 % Oral PastePSNda5652f8-585c-4697-bc65-2a613cb0ef0f1
1085728triamcinolone acetonide 0.001 MG/MG Oral PasteSCDda5652f8-585c-4697-bc65-2a613cb0ef0f1
1085728triamcinolone acetonide 0.1 % Dental PasteSYda5652f8-585c-4697-bc65-2a613cb0ef0f1
1085728triamcinolone acetonide 1 MG per GM Oral PasteSYda5652f8-585c-4697-bc65-2a613cb0ef0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0655-40007130655401 TUBE in 1 CARTON (0713-0655-40) / 5 g in 1 TUBE1 tube2017-01-130000-00-00NoNoCurrent