FDA.reportPublic FDA data

Desoximetasone

Product NDC
52565-030
11-digit product format
525650030
Labeler code
52565
Product ID
52565-030_02ded2db-0bf5-4b55-a8c7-19d06486c689
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208101
Marketing category
ANDA
Marketing start
2016-02-25
Marketing end
0000-00-00
Substance
DESOXIMETASONE
Active strength
3 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
83e6065d-d4c9-f323-882e-7de38bb4d6acProduct name920200701
7b3bb32e-bbfd-11d9-a253-bc78b5f7d7beProduct name320190204
08e04f33-a0f6-279a-7d07-56df7c40d693Product name320180605
d67f22fb-500c-d680-0b1d-d0de623f55e7Product name720171113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-030-152023-01-30C16284748780-1f386c649-c13a-0266-e053-dadaa90a7c1aDesoximetasone Ointment 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use.
52565-030-602023-01-30C16284748780-1f386c649-c13a-0266-e053-dadaa90a7c1aDesoximetasone Ointment 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use.
52565-030-992023-01-30C16284748780-1f386c649-c13a-0266-e053-dadaa90a7c1aDesoximetasone Ointment 0.25% For topical use only. Not for oral, ophthalmic, or intravaginal use.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-030-15Desoximetasone1 in 1 CARTONOINTMENT14
52565-030-15Desoximetasone15 g in 1 TUBEOINTMENT154
52565-030-60Desoximetasone60 g in 1 TUBEOINTMENT604
52565-030-60Desoximetasone1 in 1 CARTONOINTMENT14
52565-030-99Desoximetasone100 g in 1 TUBEOINTMENT1004
52565-030-99Desoximetasone1 in 1 CARTONOINTMENT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-030-15GM - Gram52565-03007916a58-7569-4d97-9028-e0555493f95612016-06-14
52565-030-60GM - Gram52565-0302f93cd07-d616-43ff-b707-be9207dcd1de12016-06-14
52565-030-99GM - Gram52565-030a0018c7a-3d76-4e8b-ba71-6de0a7ecdc3312016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-030DESOXIMETASONE (DESOXIMETASONE) OINTMENT [TELIGENT PHARMA, INC.]4Legacy NDC, 6 package rows20190911_53d8d9ed-5749-4874-a345-be768c8a0e59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197575desoximetasone 0.25 % Topical OintmentPSN53d8d9ed-5749-4874-a345-be768c8a0e594
197575desoximetasone 0.0025 MG/MG Topical OintmentSCD53d8d9ed-5749-4874-a345-be768c8a0e594
197575desoximetasone 0.25 % Topical OintmentSY53d8d9ed-5749-4874-a345-be768c8a0e594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-030-15525650030151 TUBE in 1 CARTON (52565-030-15) > 15 g in 1 TUBE1 tube2016-02-250000-00-00NoNoCurrent
52565-030-60525650030601 TUBE in 1 CARTON (52565-030-60) > 60 g in 1 TUBE1 tube2016-02-250000-00-00NoNoCurrent
52565-030-99525650030991 TUBE in 1 CARTON (52565-030-99) > 100 g in 1 TUBE1 tube2016-02-250000-00-00NoNoCurrent