FDA.reportPublic FDA data

TRIDERM

Product NDC
0316-0175
11-digit product format
003160175
Labeler code
0316
Product ID
0316-0175_4834365b-0f43-13a2-e063-6294a90a9f33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Crown Laboratories
Application
ANDA088042
Marketing category
ANDA
Marketing start
1984-03-19
Substance
TRIAMCINOLONE ACETONIDE
Active strength
5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRIDERM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1014314, 1085644, 1085686, 1085773, 1648997, 1648999

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
7a0092d1-1e8c-0d78-4f8d-d95fa15cc3cfProduct name120140508
89b93c13-4be8-69f3-b33b-63e64feffb9bProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-0175-152023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-152023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-152023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-162023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-162023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-162023-02-13C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-152023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-152023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-152023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-162023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-162023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%
0316-0175-162023-01-30C16284748780-1f386c649-b13d-0266-e053-dadaa90a7c1aTRIDERM (Triamcinolone Acetonide Cream USP), 0.025%, 0.1%, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0175-15TRIDERM1 in 1 CARTONCREAM126
0316-0175-15TRIDERM15 g in 1 TUBECREAM1526
0316-0175-16TRIDERM454 g in 1 JARCREAM45426
0316-0175-16TRIDERM1 in 1 CARTONCREAM126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0175-16GM - Gram0316-01755cb833a1-e0ba-41db-98f2-12f3f728e6da12017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
SORBITOLINACTIVE INGREDIENT506T60A25RTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11
WATERINACTIVE INGREDIENT059QF0KO0RTRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0175TRIDERM (TRIAMCINOLONE ACETONIDE) CREAM [CROWN LABORATORIES]24Current NDC, Legacy NDC, 4 package rows20231025_2c7fee2c-6f57-4de4-8803-98c0b31b07c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085644triamcinolone acetonide 0.025 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 0.1 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085686triamcinolone acetonide 0.5 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997Triderm 0.025 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773Triderm 0.1 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999Triderm 0.5 % Topical CreamPSN2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997triamcinolone acetonide 0.25 MG/ML Topical Cream [Triderm]SBD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773triamcinolone acetonide 1 MG/ML Topical Cream [Triderm]SBD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999triamcinolone acetonide 5 MG/ML Topical Cream [Triderm]SBD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085686triamcinolone acetonide 5 MG/ML Topical CreamSCD2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085644triamcinolone acetonide 0.025 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 0.1 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085686triamcinolone acetonide 0.5 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997Triderm 0.025 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773Triderm 0.1 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648997Triderm 0.25 MG/ML Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999Triderm 0.5 % Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1085773Triderm 1 MG/ML Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326
1648999Triderm 5 MG/ML Topical CreamSY2c7fee2c-6f57-4de4-8803-98c0b31b07c326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-0175-15003160175151 TUBE in 1 CARTON (0316-0175-15) / 15 g in 1 TUBE1 tube2015-03-250000-00-00NoNoCurrent
0316-0175-16003160175161 JAR in 1 CARTON (0316-0175-16) / 454 g in 1 JAR1 jar2017-09-010000-00-00NoNoCurrent