FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
40032-097
11-digit product format
400320097
Labeler code
40032
Product ID
40032-097_a6ca6e2d-56f8-4af6-967d-598ad727c779
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamcinolone Acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Novel Laboratories, Inc.
Application
ANDA207365
Marketing category
ANDA
Marketing start
2018-10-12
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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
40032-097-152024-01-30C16284748780-11030e365-2167-111a-e063-dadaa90a10e2Triamcinolone Acetonide Ointment USP, 0.1% Rx Only
40032-097-802024-01-30C16284748780-11030e365-2167-111a-e063-dadaa90a10e2Triamcinolone Acetonide Ointment USP, 0.1% Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40032-097-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT12
40032-097-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT152
40032-097-80Triamcinolone Acetonide80 g in 1 TUBEOINTMENT802
40032-097-80Triamcinolone Acetonide1 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40032-097TRIAMCINOLONE ACETONIDE OINTMENT [NOVEL LABORATORIES, INC.]2Legacy NDC, 4 package rows20181129_0afbd82a-2453-49fd-adfb-64aaca74a651.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085636triamcinolone acetonide 0.1 % Topical OintmentPSN0afbd82a-2453-49fd-adfb-64aaca74a6512
1085636triamcinolone acetonide 0.001 MG/MG Topical OintmentSCD0afbd82a-2453-49fd-adfb-64aaca74a6512
1085636triamcinolone acetonide 0.1 % Topical OintmentSY0afbd82a-2453-49fd-adfb-64aaca74a6512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
40032-097-15400320097151 TUBE in 1 CARTON (40032-097-15) > 15 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent
40032-097-80400320097801 TUBE in 1 CARTON (40032-097-80) > 80 g in 1 TUBE1 tube2018-10-120000-00-00NoNoCurrent