FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
45802-054
11-digit product format
458020054
Labeler code
45802
Product ID
45802-054_13c13dae-7f5d-4b1f-af06-c62dfdcf8f1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA087385
Marketing category
ANDA
Marketing start
2006-05-12
Substance
TRIAMCINOLONE ACETONIDE
Active strength
.25 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 ACETONIDE.25 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085633, 1085636, 1085640

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
45802-054-05Triamcinolone Acetonide454 g in 1 JAROINTMENT45413
45802-054-35Triamcinolone Acetonide15 g in 1 TUBEOINTMENT1513
45802-054-35Triamcinolone Acetonide1 in 1 CARTONOINTMENT113
45802-054-36Triamcinolone Acetonide1 in 1 CARTONOINTMENT113
45802-054-36Triamcinolone Acetonide80 g in 1 TUBEOINTMENT8013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-054-05GM - Gram45802-05443382dd3-faff-469a-ace1-3dabe12d2c0412012-07-24
45802-054-35GM - Gram45802-0541cd83933-c33e-44a6-b043-d919d52c4ccf12012-07-24
45802-054-36GM - Gram45802-054b9b48466-80a4-4d1a-b286-24574ead205b12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [PERRIGO NEW YORK INC]7
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [PERRIGO NEW YORK INC]7
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE OINTMENT [PERRIGO NEW YORK INC]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [PERRIGO NEW YORK INC]7
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
TRIAMCINOLONEACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-054TRIAMCINOLONE ACETONIDE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 5 package rows20231103_838ba2fa-5133-4975-bd99-791891a144c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085633triamcinolone acetonide 0.025 % Topical OintmentPSN838ba2fa-5133-4975-bd99-791891a144c513
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN838ba2fa-5133-4975-bd99-791891a144c513
1085640triamcinolone acetonide 0.5 % Topical OintmentPSN838ba2fa-5133-4975-bd99-791891a144c513
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCD838ba2fa-5133-4975-bd99-791891a144c513
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD838ba2fa-5133-4975-bd99-791891a144c513
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCD838ba2fa-5133-4975-bd99-791891a144c513
1085633triamcinolone acetonide 0.025 % Topical OintmentSY838ba2fa-5133-4975-bd99-791891a144c513
1085636triamcinolone acetonide 0.1 % Topical OintmentSY838ba2fa-5133-4975-bd99-791891a144c513
1085640triamcinolone acetonide 0.5 % Topical OintmentSY838ba2fa-5133-4975-bd99-791891a144c513
1085633triamcinolone acetonide 0.025 % Topical OintmentPSNc29de67c-c4c7-412b-ae5f-b5562a95a8f92
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCDc29de67c-c4c7-412b-ae5f-b5562a95a8f92
1085633triamcinolone acetonide 0.025 % Topical OintmentSYc29de67c-c4c7-412b-ae5f-b5562a95a8f92
1085633triamcinolone acetonide 0.025 % Topical OintmentPSNea6fc6e7-814d-4d42-a59a-6c0c759717441
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNea6fc6e7-814d-4d42-a59a-6c0c759717441
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCDea6fc6e7-814d-4d42-a59a-6c0c759717441
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDea6fc6e7-814d-4d42-a59a-6c0c759717441
1085633triamcinolone acetonide 0.025 % Topical OintmentSYea6fc6e7-814d-4d42-a59a-6c0c759717441
1085636triamcinolone acetonide 0.1 % Topical OintmentSYea6fc6e7-814d-4d42-a59a-6c0c759717441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-054-0545802005405454 g in 1 JAR (45802-054-05) 454 g2007-07-050000-00-00NoNoCurrent
45802-054-35458020054351 TUBE in 1 CARTON (45802-054-35) / 15 g in 1 TUBE1 tube2006-05-120000-00-00NoNoCurrent
45802-054-36458020054361 TUBE in 1 CARTON (45802-054-36) / 80 g in 1 TUBE1 tube2007-09-050000-00-00NoNoCurrent