FDA.reportPublic FDA data

Desonide

Product NDC
52565-038
11-digit product format
525650038
Labeler code
52565
Product ID
52565-038_0b2d209c-8b07-4ff6-9180-49f0e83b4443
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA212002
Marketing category
ANDA
Marketing start
2019-03-13
Marketing end
0000-00-00
Substance
DESONIDE
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52565-038IInactivated by FDA2026-08-03
excluded packagepackage52565-03852565-038-15IInactivated by FDA2026-08-03
excluded packagepackage52565-03852565-038-60IInactivated 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
A212002-001DESONIDEDESONIDE0.05%OINTMENT / TOPICAL2019-03-12

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 22:54:322026-06A212002-001DESONIDE0.05%OINTMENT / TOPICAL2019-03-12a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-038-152023-01-30C16284748780-1f386c649-b25a-0266-e053-dadaa90a7c1aDesonide Ointment, 0.05%
52565-038-602023-01-30C16284748780-1f386c649-b25a-0266-e053-dadaa90a7c1aDesonide Ointment, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-038-15Desonide15 g in 1 TUBEOINTMENT152
52565-038-15Desonide1 in 1 CARTONOINTMENT12
52565-038-60Desonide1 in 1 CARTONOINTMENT12
52565-038-60Desonide60 g in 1 TUBEOINTMENT602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-038-15GM - Gram52565-038054d8040-e6fc-4128-99e4-024ef022e55012019-06-19
52565-038-60GM - Gram52565-038d707fbbb-681d-4f99-9966-850379decec812019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-038DESONIDE OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190323_6b2b161f-8ddf-4b16-973f-b32059f9c4d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSN6b2b161f-8ddf-4b16-973f-b32059f9c4d12
204135desonide 0.0005 MG/MG Topical OintmentSCD6b2b161f-8ddf-4b16-973f-b32059f9c4d12
204135desonide 0.05 % Topical OintmentSY6b2b161f-8ddf-4b16-973f-b32059f9c4d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-038-15525650038151 TUBE in 1 CARTON (52565-038-15) > 15 g in 1 TUBE1 tube2019-03-130000-00-00NoNoCurrent
52565-038-60525650038601 TUBE in 1 CARTON (52565-038-60) > 60 g in 1 TUBE1 tube2019-03-130000-00-00NoNoCurrent