FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
0713-0226
11-digit product format
007130226
Labeler code
0713
Product ID
0713-0226_edbdc68d-056b-6aab-e053-2995a90a3fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA089797
Marketing category
ANDA
Marketing start
2015-04-14
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
Rxcui1014314, 1085644

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
0713-0226-15Triamcinolone Acetonide1 in 1 CARTONCREAM114
0713-0226-15Triamcinolone Acetonide15 g in 1 TUBECREAM1514
0713-0226-80Triamcinolone Acetonide1 in 1 CARTONCREAM114
0713-0226-80Triamcinolone Acetonide80 g in 1 TUBECREAM8014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0226-15GM - Gram0713-02263e718f21-7ff4-486e-8bab-8089c52018e412015-12-02
0713-0226-80GM - Gram0713-022640d619c1-761c-4bc3-bdc0-a6a51877640112015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Triamcinolone AcetonideACTIVE INGREDIENTF446C597KATRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Triamcinolone AcetonideACTIVE MOIETYF446C597KATRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Isopropyl PalmitateINACTIVE INGREDIENT8CRQ2TH63MTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Lanolin AlcoholsINACTIVE INGREDIENT884C3FA9HETRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Mineral OilINACTIVE INGREDIENTT5L8T28FGPTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Polyoxyl 40 StearateINACTIVE INGREDIENT13A4J4NH9ITRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Propylene Glycol StearateINACTIVE INGREDIENTMZM1I680W0TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Sorbic AcidINACTIVE INGREDIENTX045WJ989BTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58XTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RTRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) CREAM [G&W LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0226TRIAMCINOLONE ACETONIDE CREAM [COSETTE PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 4 package rows20221119_5b3bcc75-608d-23fd-91a5-0806d5fe32f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085644triamcinolone acetonide 0.025 % Topical CreamPSN5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 0.1 % Topical CreamPSN5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1085644triamcinolone acetonide 0.025 % Topical CreamSY5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 0.1 % Topical CreamSY5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY5b3bcc75-608d-23fd-91a5-0806d5fe32f514
1085644triamcinolone acetonide 0.025 % Topical CreamPSNcc8093ed-0342-4ca3-a7cc-bf764c7efccd5
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDcc8093ed-0342-4ca3-a7cc-bf764c7efccd5
1085644triamcinolone acetonide 0.025 % Topical CreamSYcc8093ed-0342-4ca3-a7cc-bf764c7efccd5
1085644triamcinolone acetonide 0.025 % Topical CreamPSN96872e39-c5f1-49c5-8d68-e231e60b68272
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCD96872e39-c5f1-49c5-8d68-e231e60b68272
1085644triamcinolone acetonide 0.025 % Topical CreamSY96872e39-c5f1-49c5-8d68-e231e60b68272
1085644triamcinolone acetonide 0.025 % Topical CreamPSNe91aeeb9-e284-4caa-8ad2-1c262badee8b1
1085644triamcinolone acetonide 0.25 MG/ML Topical CreamSCDe91aeeb9-e284-4caa-8ad2-1c262badee8b1
1085644triamcinolone acetonide 0.025 % Topical CreamSYe91aeeb9-e284-4caa-8ad2-1c262badee8b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0226-15007130226151 TUBE in 1 CARTON (0713-0226-15) / 15 g in 1 TUBE1 tube2015-04-140000-00-00NoNoCurrent
0713-0226-80007130226801 TUBE in 1 CARTON (0713-0226-80) / 80 g in 1 TUBE1 tube2015-04-140000-00-00NoNoCurrent