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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219474-001ADQUEYDIFAMILAST1%OINTMENT / TOPICALRLD, RS2026-02-12

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219474-001RE467922028-03-01U-4445Drug substance, Drug product2026-03-11
N219474-001105888932036-12-31Drug substance, Drug product2026-03-11

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219474-001NCE2031-02-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219474-001ADQUEY1%OINTMENT / TOPICALRLD, RS2026-02-12a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219474-001RE467922028-03-01U-4445Drug substance, Drug product2026-03-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219474-001105888932036-12-31Drug substance, Drug product2026-03-11a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219474-001NCE2031-02-12a50c72e98297…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T3U32GLJ0FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2738419Internal RxNorm lookup
2738424Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
46c95e41-fa29-4e11-9d94-0fd4f0291c34Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADQUEYDIFAMILASTAcrotech Biopharma Inc46c95e41-fa29-4e11-9d94-0fd4f0291c342026-02-25Adverse reactionsExact identifier
application applno (NDA): 219474
application number: NDA219474
ndc (product): 72893-017

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