FDA.reportPublic FDA data

Topicort

Product NDC
51672-5263
11-digit product format
516725263
Labeler code
51672
Product ID
51672-5263_4cd6638c-db25-e28b-e063-6294a90a4a9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
NDA018594
Marketing category
NDA
Marketing start
1985-01-17
Substance
DESOXIMETASONE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Topicort
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui141850, 1050394

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5263-1Topicort1 in 1 CARTONOINTMENT111
51672-5263-1Topicort15 g in 1 TUBEOINTMENT1511
51672-5263-2Topicort1 in 1 CARTONOINTMENT111
51672-5263-2Topicort30 g in 1 TUBEOINTMENT3011
51672-5263-3Topicort1 in 1 CARTONOINTMENT111
51672-5263-3Topicort60 g in 1 TUBEOINTMENT6011
51672-5263-5Topicort5 g in 1 TUBEOINTMENT511
51672-5263-5Topicort10 in 1 CARTONOINTMENT1011
51672-5263-7Topicort100 g in 1 TUBEOINTMENT10011
51672-5263-7Topicort1 in 1 CARTONOINTMENT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5263-1GM - Gram51672-526306effd42-563e-4fab-a370-fa1482018d9612012-07-24
51672-5263-3GM - Gram51672-5263426dbc17-a78e-45d8-a8b7-fe8ee1cd646d12012-07-24
51672-5263-7GM - Gram51672-5263634035fc-db06-4358-86b0-1a858182151612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DesoximetasoneACTIVE INGREDIENT4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
DesoximetasoneACTIVE MOIETY4E07GXB7AUTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5263TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 10 package rows20241222_96dfac6f-540f-4b7d-bcee-7e62088ebc93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141850desoximetasone 0.05 % Topical OintmentPSN96dfac6f-540f-4b7d-bcee-7e62088ebc9311
1050394Topicort 0.05 % Topical OintmentPSN96dfac6f-540f-4b7d-bcee-7e62088ebc9311
1050394desoximetasone 0.0005 MG/MG Topical Ointment [Topicort]SBD96dfac6f-540f-4b7d-bcee-7e62088ebc9311
141850desoximetasone 0.0005 MG/MG Topical OintmentSCD96dfac6f-540f-4b7d-bcee-7e62088ebc9311
141850desoximetasone 0.05 % Topical OintmentSY96dfac6f-540f-4b7d-bcee-7e62088ebc9311
1050394Topicort 0.0005 MG/MG Topical OintmentSY96dfac6f-540f-4b7d-bcee-7e62088ebc9311
1050394Topicort 0.5 MG per GM Topical OintmentSY96dfac6f-540f-4b7d-bcee-7e62088ebc9311
1050394Topicort LP 0.05 % Topical OintmentSY96dfac6f-540f-4b7d-bcee-7e62088ebc9311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5263-1516725263011 TUBE in 1 CARTON (51672-5263-1) / 15 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent
51672-5263-2516725263021 TUBE in 1 CARTON (51672-5263-2) / 30 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent
51672-5263-3516725263031 TUBE in 1 CARTON (51672-5263-3) > 60 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent
51672-5263-55167252630510 TUBE in 1 CARTON (51672-5263-5) / 5 g in 1 TUBE10 tube1985-01-170000-00-00NoNoCurrent
51672-5263-7516725263071 TUBE in 1 CARTON (51672-5263-7) / 100 g in 1 TUBE1 tube1985-01-170000-00-00NoNoCurrent