FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
63187-870
11-digit product format
631870870
Labeler code
63187
Product ID
63187-870_bac15676-050f-4656-9a21-69342aa8c408
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
ANDA086414
Marketing category
ANDA
Marketing start
2006-09-28
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
63187-870-15Triamcinolone Acetonide15 g in 1 TUBECREAM156
63187-870-15Triamcinolone Acetonide1 in 1 CARTONCREAM16
63187-870-80Triamcinolone Acetonide80 g in 1 TUBECREAM806
63187-870-80Triamcinolone Acetonide1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-870-15GM - Gram63187-8700166c24a-33a5-4784-b204-0766d790918612018-06-11
63187-870-80GM - Gram63187-870386e940e-2a1e-4ca2-ba00-093eddbd55e912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-870TRIAMCINOLONE ACETONIDE CREAM [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20230228_4aa792cc-7cd4-4a98-8730-fa36feaa9b7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014314triamcinolone acetonide 0.1 % Topical CreamPSN4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6
1014314triamcinolone acetonide 1 MG/ML Topical CreamSCD4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6
1014314triamcinolone acetonide 0.1 % Topical CreamSY4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6
1014314triamcinolone acetonide 1 MG per GM Topical CreamSY4aa792cc-7cd4-4a98-8730-fa36feaa9b7a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-870-15631870870151 TUBE in 1 CARTON (63187-870-15) / 15 g in 1 TUBE1 tube2017-07-030000-00-00NoNoCurrent
63187-870-80631870870801 TUBE in 1 CARTON (63187-870-80) / 80 g in 1 TUBE1 tube2017-07-030000-00-00NoNoCurrent