FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
51672-1282
11-digit product format
516721282
Labeler code
51672
Product ID
51672-1282_4137ed92-9021-3939-e063-6394a90ade3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040039
Marketing category
ANDA
Marketing start
1997-11-26
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
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
51672-1282-1Triamcinolone Acetonide15 g in 1 TUBECREAM158
51672-1282-1Triamcinolone Acetonide1 in 1 CARTONCREAM18
51672-1282-2Triamcinolone Acetonide1 in 1 CARTONCREAM18
51672-1282-2Triamcinolone Acetonide30 g in 1 TUBECREAM308
51672-1282-8Triamcinolone Acetonide1 in 1 CARTONCREAM18
51672-1282-8Triamcinolone Acetonide80 g in 1 TUBECREAM808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1282-1GM - Gram51672-1282249f58fd-90c9-4156-8f49-b305367dcb7e12013-02-13
51672-1282-2GM - Gram51672-1282ec6ead82-a83e-43ed-b30f-c952c4a14a9212013-02-13
51672-1282-8GM - Gram51672-12828e7a1101-fff3-4a49-86a1-cfda01278db012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
Triamcinolone AcetonideACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUTRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1282TRIAMCINOLONE ACETONIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20230225_e7e16fc2-0222-44f5-925b-928d249f55cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSNe7e16fc2-0222-44f5-925b-928d249f55cf8
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDe7e16fc2-0222-44f5-925b-928d249f55cf8
1014314triamcinolone acetonide 0.1 % Topical CreamSYe7e16fc2-0222-44f5-925b-928d249f55cf8
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYe7e16fc2-0222-44f5-925b-928d249f55cf8
1014314triamcinolone acetonide 0.1 % Topical CreamPSN99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 0.1 % Topical CreamSY99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY99f8a0e6-8ee8-4430-b1d5-1022da1d72ab6
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 0.1 % Topical CreamPSNdff0403f-1c0c-3333-e053-2a95a90a4c092
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDdff0403f-1c0c-3333-e053-2a95a90a4c092
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 0.1 % Topical CreamSYdff0403f-1c0c-3333-e053-2a95a90a4c092
1014314triamcinolone acetonide 0.1 % Topical CreamSY4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYdff0403f-1c0c-3333-e053-2a95a90a4c092
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4d29394d-4725-f912-e063-6294a90a062c2
1014314triamcinolone acetonide 0.1 % Topical CreamPSNde5bad69-a014-4e25-b1b9-214373ca57a51
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCDde5bad69-a014-4e25-b1b9-214373ca57a51
1014314triamcinolone acetonide 0.1 % Topical CreamSYde5bad69-a014-4e25-b1b9-214373ca57a51
1014314triamcinolone acetonide 1 MG per GM Topical CreamSYde5bad69-a014-4e25-b1b9-214373ca57a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1282-1516721282011 TUBE in 1 CARTON (51672-1282-1) / 15 g in 1 TUBE1 tube1997-11-260000-00-00NoNoCurrent
51672-1282-2516721282021 TUBE in 1 CARTON (51672-1282-2) / 30 g in 1 TUBE1 tube1997-11-260000-00-00NoNoCurrent
51672-1282-8516721282081 TUBE in 1 CARTON (51672-1282-8) / 80 g in 1 TUBE1 tube1997-11-260000-00-00NoNoCurrent