FDA.reportPublic FDA data

ADQUEY

Product NDC
72893-017
11-digit product format
728930017
Labeler code
72893
Product ID
72893-017_2437f76e-6dda-487c-8c3d-aa1a9059af2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Difamilast
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Acrotech Biopharma Inc
Application
NDA219474
Marketing category
NDA
Marketing start
2026-02-25
Substance
DIFAMILAST
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFAMILAST10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT3U32GLJ0F
Rxcui2738419, 2738424

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72893-017-07ADQUEY3 g in 1 TUBEOINTMENT34
72893-017-08ADQUEY27 g in 1 TUBEOINTMENT274
72893-017-09ADQUEY85 g in 1 TUBEOINTMENT854

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2738424ADQUEY 1 % Topical OintmentPSN46c95e41-fa29-4e11-9d94-0fd4f0291c344
2738419difamilast 1 % Topical OintmentPSN46c95e41-fa29-4e11-9d94-0fd4f0291c344
2738424difamilast 0.01 MG/MG Topical Ointment [Adquey]SBD46c95e41-fa29-4e11-9d94-0fd4f0291c344
2738419difamilast 0.01 MG/MG Topical OintmentSCD46c95e41-fa29-4e11-9d94-0fd4f0291c344
2738424Adquey 1 % Topical OintmentSY46c95e41-fa29-4e11-9d94-0fd4f0291c344
2738419difamilast 1 % Topical OintmentSY46c95e41-fa29-4e11-9d94-0fd4f0291c344

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72893-017-07728930017073 g in 1 TUBE (72893-017-07) 3 g2026-02-25YesNoCurrent
72893-017-087289300170827 g in 1 TUBE (72893-017-08) 27 g2026-02-25NoNoCurrent
72893-017-097289300170985 g in 1 TUBE (72893-017-09) 85 g2026-02-25NoNoCurrent