FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
68788-8356
11-digit product format
687888356
Labeler code
68788
Product ID
68788-8356_8f6d16ca-4027-4d6c-8d99-98cfbbc56eb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA040039
Marketing category
ANDA
Marketing start
2023-02-10
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
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
68788-8356-0Triamcinolone Acetonide80 g in 1 TUBECREAM806
68788-8356-0Triamcinolone Acetonide1 in 1 CARTONCREAM16
68788-8356-3Triamcinolone Acetonide30 g in 1 TUBECREAM306
68788-8356-8Triamcinolone Acetonide1 in 1 CARTONCREAM16
68788-8356-8Triamcinolone Acetonide30 g in 1 TUBECREAM306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8356-0GM - Gram68788-835638680aa7-151c-4d77-8fbd-eeaf377de43512023-04-07
68788-8356-3GM - Gram68788-8356c66bf2f4-1935-40a6-81a1-86f871418e9112023-03-13
68788-8356-8GM - Gram68788-835649de689f-34b9-4bfa-bbe8-c932245158a012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8356TRIAMCINOLONE ACETONIDE CREAM [PREFERRED PHARMACEUTICALS INC.]5Current NDC, 5 package rows20240823_99f8a0e6-8ee8-4430-b1d5-1022da1d72ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8356-0687888356001 TUBE in 1 CARTON (68788-8356-0) / 80 g in 1 TUBE1 tube2023-03-14NoNoHistorical
68788-8356-36878883560330 g in 1 TUBE (68788-8356-3) 30 g2023-03-13NoNoHistorical
68788-8356-8687888356081 in 1 CARTONHistorical