FDA.reportPublic FDA data

Desoximetasone

Product NDC
68180-948
11-digit product format
681800948
Labeler code
68180
Product ID
68180-948_09c8e716-9202-46d9-bb9a-1ef1d18a74d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desoximetasone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208044
Marketing category
ANDA
Marketing start
2017-04-25
Substance
DESOXIMETASONE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desoximetasone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESOXIMETASONE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui141850

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
68180-948-01Desoximetasone15 g in 1 TUBEOINTMENT1510
68180-948-01Desoximetasone1 in 1 CARTONOINTMENT110
68180-948-02Desoximetasone30 g in 1 TUBEOINTMENT3010
68180-948-02Desoximetasone1 in 1 CARTONOINTMENT110
68180-948-04Desoximetasone60 g in 1 TUBEOINTMENT6010
68180-948-04Desoximetasone1 in 1 CARTONOINTMENT110
68180-948-06Desoximetasone1 in 1 CARTONOINTMENT110
68180-948-06Desoximetasone100 g in 1 TUBEOINTMENT10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-948-04GM - Gram68180-94899a39185-e8a2-4aae-9c4b-fa605636be2812017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-948DESOXIMETASONE OINTMENT [LUPIN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 8 package rows20250321_b53727cf-a57f-443f-8036-3d4bd2737540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141850desoximetasone 0.05 % Topical OintmentPSNb53727cf-a57f-443f-8036-3d4bd273754010
141850desoximetasone 0.0005 MG/MG Topical OintmentSCDb53727cf-a57f-443f-8036-3d4bd273754010
141850desoximetasone 0.05 % Topical OintmentSYb53727cf-a57f-443f-8036-3d4bd273754010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-948-01681800948011 TUBE in 1 CARTON (68180-948-01) > 15 g in 1 TUBE1 tube2017-04-250000-00-00NoNoCurrent
68180-948-02681800948021 TUBE in 1 CARTON (68180-948-02) > 30 g in 1 TUBE1 tube2017-04-250000-00-00NoNoCurrent
68180-948-04681800948041 TUBE in 1 CARTON (68180-948-04) / 60 g in 1 TUBE1 tube2017-04-250000-00-00NoNoCurrent
68180-948-06681800948061 TUBE in 1 CARTON (68180-948-06) > 100 g in 1 TUBE1 tube2017-04-250000-00-00NoNoCurrent