FDA.reportPublic FDA data

Triamcinolone Acetonide

Product NDC
52565-048
11-digit product format
525650048
Labeler code
52565
Product ID
52565-048_a6cb1ad5-f103-47f6-9dea-72b8432ef3e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamcinolone acetonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208590
Marketing category
ANDA
Marketing start
2017-03-03
Marketing end
0000-00-00
Substance
TRIAMCINOLONE ACETONIDE
Active strength
5 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52565-048IInactivated by FDA2026-08-03
excluded packagepackage52565-04852565-048-15IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208590-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208590-001TRIAMCINOLONE ACETONIDE0.5%OINTMENT / TOPICAL2017-03-03a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPb05fddfb-7d63-42d8-b41a-003492d3922c2022-09-01Adverse reactionsExact identifier
application applno (ANDA): 208590
application number: ANDA208590
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPe5e3a38d-717d-4412-80d3-7130100add0a2020-09-01Adverse reactionsExact identifier
application applno (ANDA): 208590
application number: ANDA208590

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
52565-048-152023-01-30C16284748780-1f386c64a-1530-0266-e053-dadaa90a7c1aTriamcinolone Acetonide Ointment USP, 0.5% For Dermatologic Use Only Not For Ophthalmic Use Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-048-15Triamcinolone Acetonide15 g in 1 TUBEOINTMENT156
52565-048-15Triamcinolone Acetonide1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-048-15GM - Gram52565-0481367ab3b-dad9-410e-97bc-63dad379b38712017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-048TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) OINTMENT [TELIGENT PHARMA, INC.]6Legacy NDC, 2 package rows20211009_76d9b45a-9efd-efa3-00ad-d32a24ef0ff8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085640triamcinolone acetonide 0.5 % Topical OintmentPSN76d9b45a-9efd-efa3-00ad-d32a24ef0ff86
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCD76d9b45a-9efd-efa3-00ad-d32a24ef0ff86
1085640triamcinolone acetonide 0.5 % Topical OintmentSY76d9b45a-9efd-efa3-00ad-d32a24ef0ff86
1085640triamcinolone acetonide 0.5 % Topical OintmentPSNe5e3a38d-717d-4412-80d3-7130100add0a4
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCDe5e3a38d-717d-4412-80d3-7130100add0a4
1085640triamcinolone acetonide 0.5 % Topical OintmentSYe5e3a38d-717d-4412-80d3-7130100add0a4
1085640triamcinolone acetonide 0.5 % Topical OintmentPSNcb6c3460-4aaa-487a-97ba-a176af212f951
1085640triamcinolone acetonide 0.005 MG/MG Topical OintmentSCDcb6c3460-4aaa-487a-97ba-a176af212f951
1085640triamcinolone acetonide 0.5 % Topical OintmentSYcb6c3460-4aaa-487a-97ba-a176af212f951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-048-15525650048151 TUBE in 1 CARTON (52565-048-15) > 15 g in 1 TUBE1 tube2017-03-030000-00-00NoNoCurrent