FDA.reportPublic FDA data

Topicort

Product NDC
51672-5203
11-digit product format
516725203
Labeler code
51672
Product ID
51672-5203_f42ec0f5-b9db-4cc1-b466-4ff4869d8a8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA074286
Marketing category
ANDA
Marketing start
1992-12-15
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
51672-5203-12025-07-29C16284748780-13b156c62-3441-fb37-e063-e6dba90a4e07Topicort ® (Desoximetasone Ointment USP) 0.25%
51672-5203-32025-07-29C16284748780-13b156c62-3441-fb37-e063-e6dba90a4e07Topicort ® (Desoximetasone Ointment USP) 0.25%
51672-5203-52025-07-29C16284748780-13b156c62-3441-fb37-e063-e6dba90a4e07Topicort ® (Desoximetasone Ointment USP) 0.25%
51672-5203-72025-07-29C16284748780-13b156c62-3441-fb37-e063-e6dba90a4e07Topicort ® (Desoximetasone Ointment USP) 0.25%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5203-1Topicort15 g in 1 TUBEOINTMENT155
51672-5203-1Topicort1 in 1 CARTONOINTMENT15
51672-5203-3Topicort60 g in 1 TUBEOINTMENT605
51672-5203-3Topicort1 in 1 CARTONOINTMENT15
51672-5203-5Topicort5 g in 1 TUBEOINTMENT55
51672-5203-7Topicort1 in 1 CARTONOINTMENT15
51672-5203-7Topicort100 g in 1 TUBEOINTMENT1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5203-1GM - Gram51672-5203aafe18e5-410d-410f-8d09-57715d0e08c912012-07-24
51672-5203-3GM - Gram51672-5203a51347b4-8b17-4fb9-95dd-199bd9f8a20412012-07-24
51672-5203-7GM - Gram51672-520385a5781f-7997-461f-92af-da9c4ab17d5012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
desoximetasoneACTIVE INGREDIENT4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
desoximetasoneACTIVE MOIETY4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
coconut oilINACTIVE INGREDIENTQ9L0O73W7LTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5203TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Legacy NDC, 7 package rows20190308_612e53ec-720c-47ba-97bc-5db85064e33b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197575desoximetasone 0.25 % Topical OintmentPSN612e53ec-720c-47ba-97bc-5db85064e33b5
94348Topicort 0.25 % Topical OintmentPSN612e53ec-720c-47ba-97bc-5db85064e33b5
94348desoximetasone 0.0025 MG/MG Topical Ointment [Topicort]SBD612e53ec-720c-47ba-97bc-5db85064e33b5
197575desoximetasone 0.0025 MG/MG Topical OintmentSCD612e53ec-720c-47ba-97bc-5db85064e33b5
197575desoximetasone 0.25 % Topical OintmentSY612e53ec-720c-47ba-97bc-5db85064e33b5
94348Topicort 0.0025 MG/MG Topical OintmentSY612e53ec-720c-47ba-97bc-5db85064e33b5
94348Topicort 0.25 % Topical OintmentSY612e53ec-720c-47ba-97bc-5db85064e33b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5203-1516725203011 TUBE in 1 CARTON (51672-5203-1) > 15 g in 1 TUBE1 tube1992-12-150000-00-00NoNoCurrent
51672-5203-3516725203031 TUBE in 1 CARTON (51672-5203-3) > 60 g in 1 TUBE1 tube1992-12-150000-00-00NoNoCurrent
51672-5203-5516725203055 g in 1 TUBE (51672-5203-5) 5 g1992-12-150000-00-00NoNoCurrent
51672-5203-7516725203071 TUBE in 1 CARTON (51672-5203-7) > 100 g in 1 TUBE1 tube1992-12-150000-00-00NoNoCurrent