FDA.reportPublic FDA data

KENALOG-10

Product NDC
50090-0295
11-digit product format
500900295
Labeler code
50090
Product ID
50090-0295_0e119f28-b473-4083-859e-fb153fa9c43b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRIAMCINOLONE ACETONIDE
Dosage form
INJECTION, SUSPENSION
Route
INTRA-ARTICULAR; INTRALESIONAL
Labeler
A-S Medication Solutions
Application
NDA012041
Marketing category
NDA
Marketing start
2009-06-01
Substance
TRIAMCINOLONE ACETONIDE
Active strength
10 mg/mL
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
KENALOG-10
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMCINOLONE ACETONIDE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF446C597KA
Rxcui1085750, 1085752

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0295-12023-03-17C16284748780-1f386c64a-00b0-0266-e053-dadaa90a7c1aKENALOG ® -10 INJECTION (triamcinolone acetonide injectable suspension, USP)
50090-0295-12023-01-30C16284748780-1f386c64a-00b0-0266-e053-dadaa90a7c1aKENALOG ® -10 INJECTION (triamcinolone acetonide injectable suspension, USP)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0295-1KENALOG-101 in 1 CARTONINJECTION, SUSPENSION118
50090-0295-1KENALOG-105 mL in 1 VIAL, MULTI-DOSEINJECTION, SUSPENSION518

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0295-1ML - Milliliter50090-0295bf8017ef-4e4e-49c0-9383-71e04e84cf4a12018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0295KENALOG-10 (TRIAMCINOLONE ACETONIDE) INJECTION, SUSPENSION [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20230318_653ec195-0966-478d-be47-6b1ff158e111.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085752Kenalog 10 MG/ML Injectable SuspensionPSN653ec195-0966-478d-be47-6b1ff158e11118
1085750triamcinolone acetonide 10 MG/ML Injectable SuspensionPSN653ec195-0966-478d-be47-6b1ff158e11118
1085752triamcinolone acetonide 10 MG/ML Injectable Suspension [Kenalog]SBD653ec195-0966-478d-be47-6b1ff158e11118
1085750triamcinolone acetonide 10 MG/ML Injectable SuspensionSCD653ec195-0966-478d-be47-6b1ff158e11118
1085752Kenalog 10 MG/ML Injectable SuspensionSY653ec195-0966-478d-be47-6b1ff158e11118
1085752Kenalog-10 10 MG/ML Injectable SuspensionSY653ec195-0966-478d-be47-6b1ff158e11118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0295-1500900295011 VIAL, MULTI-DOSE in 1 CARTON (50090-0295-1) / 5 mL in 1 VIAL, MULTI-DOSE2016-06-290000-00-00NoNoCurrent