Home NDC 0472-0479 Desoximetasone
Product NDC 0472-0479
11-digit product format 004720479
Labeler code 0472
Product ID 0472-0479_01addff4-d328-41d9-8e13-42f20819c2e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desoximetasone
Dosage form OINTMENT
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA204965
Marketing category ANDA
Marketing start 2016-11-21
Marketing end 2026-11-30
Substance DESOXIMETASONE
Active strength 2.5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Current FDA listing Yes Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204965-001 DESOXIMETASONE DESOXIMETASONE 0.25% OINTMENT / TOPICAL AB 2016-11-07
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A204965-001 AB
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNINGS Keep out of reach of children.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitus Allergic contact dermatitis Miliaria In controlled clinical studies the incidence of adverse reactions was low (0.3%) for desoximetasone ointment, 0.25% and consisted of development of comedones at the site of application.
adverse reactions table Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitus Allergic contact dermatitis Miliaria
Additional Listing Data#
Finished product Yes
Brand name base Desoximetasone Active Ingredients# Ingredient, Strength table Ingredient Strength DESOXIMETASONE 2.5 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii 4E07GXB7AU Rxcui 197575
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0472-0479-15 Desoximetasone 15 g in 1 TUBE OINTMENT 15 12 0472-0479-15 Desoximetasone 1 in 1 CARTON OINTMENT 1 12 0472-0479-60 Desoximetasone 1 in 1 CARTON OINTMENT 1 12 0472-0479-60 Desoximetasone 60 g in 1 TUBE OINTMENT 60 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-0479 DESOXIMETASONE OINTMENT [ACTAVIS PHARMA, INC.] 11 Current NDC, Legacy NDC, 4 package rows 20211218_c342beac-547b-4b0b-a39c-44a0961f924b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0472-0479-15 00472047915 1 TUBE in 1 CARTON (0472-0479-15) / 15 g in 1 TUBE 1 tube 2016-11-21 2026-11-30 No No Current 0472-0479-60 00472047960 1 TUBE in 1 CARTON (0472-0479-60) / 60 g in 1 TUBE 1 tube 2016-11-21 2026-11-30 No No Current