FDA.reportPublic FDA data

DESOXIMETASONE

Product NDC
68180-946
11-digit product format
681800946
Labeler code
68180
Product ID
68180-946_5752644f-f41f-4d69-9f97-ef3818fd482a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESOXIMETASONE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208104
Marketing category
ANDA
Marketing start
2017-05-10
Substance
DESOXIMETASONE
Active strength
2.5 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
DESOXIMETASONE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4E07GXB7AU
Rxcui197575

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
68180-946-01DESOXIMETASONE15 g in 1 TUBEOINTMENT159
68180-946-01DESOXIMETASONE1 in 1 CARTONOINTMENT19
68180-946-02DESOXIMETASONE30 g in 1 TUBEOINTMENT309
68180-946-02DESOXIMETASONE1 in 1 CARTONOINTMENT19
68180-946-04DESOXIMETASONE1 in 1 CARTONOINTMENT19
68180-946-04DESOXIMETASONE60 g in 1 TUBEOINTMENT609
68180-946-06DESOXIMETASONE1 in 1 CARTONOINTMENT19
68180-946-06DESOXIMETASONE100 g in 1 TUBEOINTMENT1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-946-01GM - Gram68180-9469516e827-3c76-4c79-8e9b-94cdc3bb794d12017-05-04
68180-946-04GM - Gram68180-94611c54036-7d8b-4602-8117-8c549502528c12017-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-946DESOXIMETASONE OINTMENT [LUPIN PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 8 package rows20250227_65e5f3c5-ef24-4e21-9427-fa0d5c283098.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197575desoximetasone 0.25 % Topical OintmentPSN65e5f3c5-ef24-4e21-9427-fa0d5c2830989
197575desoximetasone 0.0025 MG/MG Topical OintmentSCD65e5f3c5-ef24-4e21-9427-fa0d5c2830989
197575desoximetasone 0.25 % Topical OintmentSY65e5f3c5-ef24-4e21-9427-fa0d5c2830989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-946-01681800946011 TUBE in 1 CARTON (68180-946-01) / 15 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
68180-946-02681800946021 TUBE in 1 CARTON (68180-946-02) > 30 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
68180-946-04681800946041 TUBE in 1 CARTON (68180-946-04) / 60 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent
68180-946-06681800946061 TUBE in 1 CARTON (68180-946-06) > 100 g in 1 TUBE1 tube2017-05-100000-00-00NoNoCurrent