FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
0168-0006
11-digit product format
001680006
Labeler code
0168
Product ID
0168-0006_4ecf8bca-6585-4eed-88c7-c261a622d1cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA085691
Marketing category
ANDA
Marketing start
1978-02-14
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 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
Triamcinolone Acetonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085633, 1085636

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
0168-0006-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT158
0168-0006-16Triamcinolone Acetonide454 g in 1 JAROINTMENT4548
0168-0006-80Triamcinolone Acetonide80 g in 1 TUBEOINTMENT808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0006-15GM - Gram0168-000639f09506-f0d9-4844-9438-7ea981de245312012-07-24
0168-0006-16GM - Gram0168-000604cb4152-a722-4853-93bd-e118f96e4c3f12012-07-24
0168-0006-80GM - Gram0168-00061dcd6459-8a17-420e-9452-4b07bdd37f7712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIAMCINOLONE ACETONIDEACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
TRIAMCINOLONE ACETONIDEACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTRIAMCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]5
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1
TriamcinoloneACTIVE MOIETY1ZK20VI6TYTRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0006TRIAMCINOLONE ACETONIDE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 3 package rows20180426_a5cc640f-c72d-49fa-b970-906c9ffd8629.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085633triamcinolone acetonide 0.025 % Topical OintmentPSNa5cc640f-c72d-49fa-b970-906c9ffd86298
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNa5cc640f-c72d-49fa-b970-906c9ffd86298
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCDa5cc640f-c72d-49fa-b970-906c9ffd86298
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDa5cc640f-c72d-49fa-b970-906c9ffd86298
1085633triamcinolone acetonide 0.025 % Topical OintmentSYa5cc640f-c72d-49fa-b970-906c9ffd86298
1085636triamcinolone acetonide 0.1 % Topical OintmentSYa5cc640f-c72d-49fa-b970-906c9ffd86298
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN14230a12-656e-4fa6-937a-ed0dd41579207
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD14230a12-656e-4fa6-937a-ed0dd41579207
1085636triamcinolone acetonide 0.1 % Topical OintmentSY14230a12-656e-4fa6-937a-ed0dd41579207
1085633triamcinolone acetonide 0.025 % Topical OintmentPSNb20c22b2-9a74-4b71-9015-40838fd2d1932
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNb20c22b2-9a74-4b71-9015-40838fd2d1932
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCDb20c22b2-9a74-4b71-9015-40838fd2d1932
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDb20c22b2-9a74-4b71-9015-40838fd2d1932
1085633triamcinolone acetonide 0.025 % Topical OintmentSYb20c22b2-9a74-4b71-9015-40838fd2d1932
1085636triamcinolone acetonide 0.1 % Topical OintmentSYb20c22b2-9a74-4b71-9015-40838fd2d1932
1085633triamcinolone acetonide 0.025 % Topical OintmentPSN3f33ae63-5653-4a75-9f74-19d40ae202091
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN3f33ae63-5653-4a75-9f74-19d40ae202091
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCD3f33ae63-5653-4a75-9f74-19d40ae202091
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD3f33ae63-5653-4a75-9f74-19d40ae202091
1085633triamcinolone acetonide 0.025 % Topical OintmentSY3f33ae63-5653-4a75-9f74-19d40ae202091
1085636triamcinolone acetonide 0.1 % Topical OintmentSY3f33ae63-5653-4a75-9f74-19d40ae202091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0006-150016800061515 g in 1 TUBE (0168-0006-15) 15 g1978-02-140000-00-00NoNoCurrent
0168-0006-1600168000616454 g in 1 JAR (0168-0006-16) 454 g1978-02-140000-00-00NoNoCurrent
0168-0006-800016800068080 g in 1 TUBE (0168-0006-80) 80 g1978-02-140000-00-00NoNoCurrent