FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
0713-0228
11-digit product format
007130228
Labeler code
0713
Product ID
0713-0228_2874a9b6-bcdd-0f7c-e063-6394a90ace1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA089796
Marketing category
ANDA
Marketing start
2015-09-10
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
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
0713-0228-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT113
0713-0228-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT1513
0713-0228-31Triamcinolone Acetonide1 in 1 CARTONOINTMENT113
0713-0228-31Triamcinolone Acetonide30 g in 1 TUBEOINTMENT3013
0713-0228-80Triamcinolone Acetonide1 in 1 CARTONOINTMENT113
0713-0228-80Triamcinolone Acetonide80 g in 1 TUBEOINTMENT8013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0228-15GM - Gram0713-022812734d2b-4648-4872-88a3-25e754d2201f12015-12-02
0713-0228-31GM - Gram0713-02281ed3f6d5-cb08-4070-a7c1-5a070f91c2e412025-01-14
0713-0228-80GM - Gram0713-02280da61282-c9cb-4a3e-bcf7-44d9d270c52612015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]3
Triamcinolone AcetonideACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]3
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]3
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [G&W LABORATORIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0228TRIAMCINOLONE ACETONIDE OINTMENT [COSETTE PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 6 package rows20241207_5397395a-2d13-9311-7cb2-c316339d4acc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085633triamcinolone acetonide 0.025 % Topical OintmentPSN5397395a-2d13-9311-7cb2-c316339d4acc13
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN5397395a-2d13-9311-7cb2-c316339d4acc13
1085633triamcinolone acetonide 0.00025 MG/MG Topical OintmentSCD5397395a-2d13-9311-7cb2-c316339d4acc13
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD5397395a-2d13-9311-7cb2-c316339d4acc13
1085633triamcinolone acetonide 0.025 % Topical OintmentSY5397395a-2d13-9311-7cb2-c316339d4acc13
1085636triamcinolone acetonide 0.1 % Topical OintmentSY5397395a-2d13-9311-7cb2-c316339d4acc13
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNbcac4d00-b5f7-4a25-9088-c3731903ac337
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDbcac4d00-b5f7-4a25-9088-c3731903ac337
1085636triamcinolone acetonide 0.1 % Topical OintmentSYbcac4d00-b5f7-4a25-9088-c3731903ac337
1085636triamcinolone acetonide 0.1 % Topical OintmentPSNef5ccb76-6074-487a-8f25-0d696ffcc0855
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCDef5ccb76-6074-487a-8f25-0d696ffcc0855
1085636triamcinolone acetonide 0.1 % Topical OintmentSYef5ccb76-6074-487a-8f25-0d696ffcc0855
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN2fc08cae-77e2-5e67-e063-6294a90aa5933
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD2fc08cae-77e2-5e67-e063-6294a90aa5933
1085636triamcinolone acetonide 0.1 % Topical OintmentSY2fc08cae-77e2-5e67-e063-6294a90aa5933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0228-15007130228151 TUBE in 1 CARTON (0713-0228-15) / 15 g in 1 TUBE1 tube2015-09-100000-00-00NoNoCurrent
0713-0228-31007130228311 TUBE in 1 CARTON (0713-0228-31) / 30 g in 1 TUBE1 tube2024-12-06NoNoCurrent
0713-0228-80007130228801 TUBE in 1 CARTON (0713-0228-80) / 80 g in 1 TUBE1 tube2015-09-100000-00-00NoNoCurrent